title: Презентация на тему: Ресинхронизирующая терапия: программирование устройств

text:
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
Position RV lead for optimal defibrillation threshold
Position LV and RV lead tips to maximize separation for cardiac resynchronization therapy
Test for oversensing in RV and RV + LV
Confirm the LV lead pin is properly fixed in the header before testing the defibrillation threshold
Permanent Pacing Configurations
RV or RV+LV (No LV Only Pacing)
Flexible ATP Therapies
RV, LV, or RV+LV
InSync® ICD Model 7272Implant Suggestions
InSync® ICD Model 7272Threshold Tests
Check each lead separately
LV threshold
EGM: LV tip to HVA
RV threshold
EGM: RV tip to RV coil
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
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Second Level
Third Level
Fourth Level
Fifth Level
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Second level
Third level
Fourth level
Fifth level
V1
V2
+
-
+
-
V1
V2
Ring
Tip

VEGM

RV
LV
AS
AV
PVARP
AR
AS
V
AV
VR
PVARP
PVARP ext
           TARP
400 ms
Rate histrogram for 1 month,
then high rate diagnostics
Diagnostics
ON
VSP
ON
NCAP
Bipolar
V Polarity
Bipolar
A Polarity
> P Wave
Ventricular Sensitivity
0.5 mV
Atrial Sensitivity
2 x higher of RV or LV threshold
V Output
OFF
PVC Response
ON
PMT Intervention
250 ms
PVARP
ON, start rate @ 100 ppm
RA-AV
As optimized via echo (or 100 ms)
SAV
Programmed SAV + 30 ms
PAV
140 ppm
UTR
LR
OFF (unless AF apparent)
Mode Switch
DDD (R/R as needed)
Mode
Porciani et al. Eur Heart J Suppl 2000;  2: J23-J30
Nishimura et al. J Am Coll Cardiol. 1995; 25:281.
Walker et al. Europace 2000;I(suppl D): abstract 212/5
Click to Start/Stop
0
40
80
120
160
200
162
137
MIRACLE Trial
0
10
20
30
40
50
60
70
80
90
100
93%
Success
(536/579)
95%
Success
(318/334)
Attain Family w/ OTW
80
85
90
95
100
MIRACLE
95 %
97%

87 x 57

34 J

(50% tilt)

Far Field
Near Field
Far Field
Near Field
EGM Sources for EGM 2
EGM Sources for EGM 1
*In the InSync ICD,  the ring in a true bipolar RV lead is NOT active.
RV Testing
LV Testing
Defib Lead
 5832 Cables
 5832 Cables
 Analyzer
Atrial Bipolar
 LV Unipolar
 5832 Cables
 5832 Cable
 Analyzer
 DF-1 RV
 DF-1 SVC
InSync® ICD Model 7272Threshold Tests
NOTE: Make sure the SVC coil and the RV coil are connected properly since the RV DF-1 pin is the anode.
EGM 1 (Atip to Aring)
EGM 2 (RV tip to RV coil)
Stored EGM
Sinus Tach, Afib/Flutter ON
SVT Criteria
 2x Higher Ventricular Chamber Threshold
Ventricular Amplitude
ON, Start Rate = 100 bpm
RAAV
SAV + 30 ms
PAV
As optimized by echo (or 100 ms)
SAV
Off (unless AF)
Mode Switch
140 bpm, if possible
Upper Tracking Rate*
< intrinsic unless rate support required
Lower Rate
DDD/R
Mode
Measure the RV and LV thresholds separately!
Check battery
voltage and
last charge
Check lead
 impedance
Check % of
ventricular
pacing
Click to Start/Stop
The results presented in these case studies are specific to these individual patients. Patient results will vary, not every response is the same.
The results presented in these case studies are specific to these individual patients. Patient results will vary, not every response is the same.
Patient:

Cardiovascular History/Diagnostic Evaluation:
Courtesy of Dr. Eric Burton, Southwest Florida Heart Group, Fort Myers, Fl
ACE inhibitor: lisinopril 20 mg once per day
Beta blocker: carvedilol 25 mg twice daily
Diuretic: furosemide 40 mg twice daily
Digoxin 0.25 mg once per day
Nitrate: isosorbide mononitrate 30 mg once per day
Aspirin 81 mg once per day
Anticoagulant: warfarin sodium (as directed).
Lipid lowering: atorvastatin calcium 10 mg once per day
Baseline Cardiac Medications:
Cardiac Resynchronization Therapy:
*Patient was enrolled in the initial phase in which patients were randomized for three months
Courtesy of Dr. Eric Burton, Southwest Florida Heart Group, Fort Myers, Fl
50
II
391 meters
13.9 ml/kg/min
702 seconds
28%
120 ms
Walks at least one mile a day, remodeling home, sleeps 6-8 hours a night, working part-time, and recently helped build a mission church in Nicaragua.
65
III
319 meters
12.2 ml/kg/min
619 seconds
23%
160 ms
Unable to walk room-to-room, unable to carry on daily activities; sleeping average of 22 hours a day.
Quality of Life Score
NYHA Class
Six-Minute Walk
Peak VO2
Peak Exercise Time
EF (core lab calc)
QRS Duration
Symptoms

12-Month Evaluation after Implant (Nov 1999)
Baseline (Nov 1998)
Cardiac Resynchronization Therapy Results:
Courtesy of Dr. Eric Burton, Southwest Florida Heart Group, Fort Myers, Fl
Cardiac catheterization, Jan 2000 - global hypokinesis with EF 25-30%, normal LV filling pressures.  Luminal coronary atherosclerosis.
Echo, Jan 2000 -  left atrial size 3.6 cm.  Dilated left ventricle with LVEDD 58 mm.  EF 30-35%.  Anterior wall akinetic, no significant valvular abnormalities.
ECG, March 2000 - normal sinus rhythm, left axis deviation, LBBB, QRS 160 msec.
Hyperlipidemia
No indication for pacemaker or ICD; No history of atrial arrhythmias
Patient:
Cardiovascular History/Diagnostic Evaluation:
Courtesy of Dr. David DeLurgio, Crawford Long Hospital, Atlanta, Ga
ACE inhibitor: enalapril maleate 10 mg once per day
Beta blocker: carvedilol 6.25 mg once per day
Diuretic: furosemide 40 mg once per day
Digoxin 0.125 mg once per day
Aspirin 81 mg once per day
Potassium replacement: 20 mEq once per day
Baseline Cardiac Medications:
Cardiac Resynchronization Therapy:
Courtesy of Dr. David DeLurgio, Crawford Long Hospital, Atlanta, Ga
4
I
335 meters
16.39 ml/kg/min
478 seconds
39%
160 ms
Able to do daily housework, laundry, cooking, vacuuming without shortness of breath. No limitation in activity and regularly goes dancing.
82
III
259 meters
15.7 ml/kg/min
215 seconds
34%
160 ms
Exertional dyspnea with chest discomfort, extreme fatigue with any exercise, palpitations, 2-pillow orthopnea, paroxysmal nocturnal dyspnea, inability to do housework.
Quality of Life Score
NYHA Class
Six-Minute Walk
Peak VO2
Peak Exercise Time
EF (core lab calc)
QRS Duration
Symptoms

12-Month Evaluation after Implant (March 2001)
Baseline (March 2000)
Cardiac Resynchronization Therapy Results:
Courtesy of Dr. David DeLurgio, Crawford Long Hospital, Atlanta, Ga
The data reflected in the third column (12-month evaluation) corresponds to 9-months of cardiac resynchronization therapy for this patient.
Note: This patient was enrolled in the initial 3-month randomization period of the MIRACLE trial. Cross-over occurred and the patient began receiving therapy 3 months post-implant.
Physicians Note: The following slides may be used as a format for your own case studies if you wish to insert clinical information for your patients who have received cardiac resynchronization therapy.
.

 Longevity: Ventricular amplitude 4.0 volts at .4 ms.
Emergency Fixed Burst or VVI pacing is RV only
Sprint leads with true bipolar sensing are probably the leads of choice, even if the ring is not used.  The physician may want to upgrade later to a true bipolar cardiac resynchronization system.
We recommend that the LV and RV leads have good physical and electrical separation to allow for the greatest cardiac resynchronization benefits. Defibrillation takes precedence over CRT, and there may be an occasion when ideal LV placement has to be secondary to RV lead placement.
Even though the InSync ICD senses only on the RV lead, the capture morphology changes when pacing BiV and for this reason, one should test oversensing in the RV, and BiV configurations.

Sprint Models 6944 and 6947 true bipolar leads  have the same tip-to-coil spacing as the integrated bipolar leads (12 mm).    Remember, there is a higher chance of far field  P- wave sensing using the Sprint Models 6944 and 6947 since the coil was extended for increased surface area.  The tip to proximal end of the distal coil length in these leads is 6.9 cm vs. 6.2 cm in the integrated bipolar leads, Sprint Models 6942 and 6945.  In simple terms, the distal coil is closer to the right atrium. Therefore, far field P-wave sensing must be checked if using the true bipolar RV defibrillation leads.

Consider battery changes in the future when selecting a true bipolar lead, since the ring will be inactive in the InSync ICD.
When connecting the RV lead for pacing/sensing testing, remember to disregard the RV ring connection and connect the black clip to the RV tip electrode, and connect the red clip to the RV distal coil.
This diagram shows how one would use the adaptors, Models 5103 and 5114,  to check biventricular thresholds of an ICD system.  Ignore the hook up for the atrial lead.
Here is a graphic of the header to make sure there is proper connection. (The can is etched also) Make sure the LV lead is in the bottom port and the RV lead is in the middle port.
An adaptor for LV-1 to IS-1 can be used.  (Medtronic Model # LV/IS-10, and one package of medical adhesive, Medtronic Model 080118, will also be needed.)
*If the RV lead impedance is less than 300 ohms at follow-up, when the device is biventricular pacing, the pacing output on the leading edge of the pulse output will be okay but the trailing edge may be less and, for this reason, the biventricular capture threshold may be HIGHER!!!   Therefore, check a biventricular threshold (not normally done) to assure the patient will receive biventricular pacing if the RV lead impedance is less than 300 ohms.  The Upper Tracking Rate should be set to a value above the patient's expected maximum intrinsic rate to ensure that cardiac resynchronization therapy is provided throughout the range of patient activity.
A combination of high Upper Sensor Rate, high Upper Tracking Rate, and long refractory period may result in competitive atrial pacing if NCAP is not enabled.

In this device, separate thresholds can be obtained. The EGM does not automatically change when switching from an RV test to an LV test.
Program the device based on the higher of the 2 thresholds.
At follow-up, check the % of ventricular pacing, battery, last charge, and lead impedance. (Remember, NO LV lead impedance given with this device.)
Perform an EGM amplitude test to verify the integrity of the RV, and RA leads.

InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
Position RV lead for optimal defibrillation threshold
Position LV and RV lead tips to maximize separation for cardiac resynchronization therapy
Test for oversensing in RV and RV + LV
Confirm the LV lead pin is properly fixed in the header before testing the defibrillation threshold
Permanent Pacing Configurations
RV or RV+LV (No LV Only Pacing)
Flexible ATP Therapies
RV, LV, or RV+LV
InSync® ICD Model 7272Implant Suggestions
InSync® ICD Model 7272Threshold Tests
Check each lead separately
LV threshold
EGM: LV tip to HVA
RV threshold
EGM: RV tip to RV coil
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Implant Suggestions
InSync® ICD Model 7272Threshold Tests
Check each lead separately
LV threshold
EGM: LV tip to HVA
RV threshold
EGM: RV tip to RV coil
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Implant Suggestions
InSync® ICD Model 7272Threshold Tests
Check each lead separately
LV threshold
EGM: LV tip to HVA
RV threshold
EGM: RV tip to RV coil
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Implant Suggestions
InSync® ICD Model 7272Threshold Tests
Check each lead separately
LV threshold
EGM: LV tip to HVA
RV threshold
EGM: RV tip to RV coil
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Implant Suggestions
InSync® ICD Model 7272Threshold Tests
Check each lead separately
LV threshold
EGM: LV tip to HVA
RV threshold
EGM: RV tip to RV coil
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Threshold Tests
Check each lead separately
LV threshold
EGM: LV tip to HVA
RV threshold
EGM: RV tip to RV coil
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
*In the InSync ICD,  the ring in a true bipolar RV lead is NOT active.

InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Threshold Tests
Check each lead separately
LV threshold
EGM: LV tip to HVA
RV threshold
EGM: RV tip to RV coil
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Threshold Tests
Check each lead separately
LV threshold
EGM: LV tip to HVA
RV threshold
EGM: RV tip to RV coil
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Threshold Tests
Check each lead separately
LV threshold
EGM: LV tip to HVA
RV threshold
EGM: RV tip to RV coil
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Threshold Tests
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
RV Testing
LV Testing
Defib Lead
 5832 Cables
 5832 Cables
 Analyzer
Atrial Bipolar
 LV Unipolar
 5832 Cables
 5832 Cable
 Analyzer
 DF-1 RV
 DF-1 SVC
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Defib Lead
 5832 Cables
 5832 Cables
 Analyzer
Atrial Bipolar
 LV Unipolar
 5832 Cables
 5832 Cable
 Analyzer
 DF-1 RV
 DF-1 SVC
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Two DF-1 ports
Three IS-1 ports
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
NOTE: Make sure the SVC coil and the RV coil are connected properly since the RV DF-1 pin is the anode.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Model 7272Programming Recommendations
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
EGM 1 (Atip to Aring)
EGM 2 (RV tip to RV coil)
Stored EGM
Sinus Tach, Afib/Flutter ON
SVT Criteria
 2x Higher Ventricular Chamber Threshold
Ventricular Amplitude
ON, Start Rate = 100 bpm
RAAV
SAV + 30 ms
PAV
As optimized by echo (or 100 ms)
SAV
Off (unless AF)
Mode Switch
140 bpm, if possible
Upper Tracking Rate*
< intrinsic unless rate support required
Lower Rate
DDD/R
Mode
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
EGM 1 (Atip to Aring)
EGM 2 (RV tip to RV coil)
Stored EGM
Sinus Tach, Afib/Flutter ON
SVT Criteria
Ventricular Amplitude
ON, Start Rate = 100 bpm
RAAV
SAV + 30 ms
PAV
SAV
Mode Switch
140 bpm,
Upper Tracking Rate*
Lower Rate
DDD/R
Mode
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Ensure CRT Delivery
Take RV and LV thresholds
 Set ventricular output based on higher of RV, LV threshold
Program Upper Tracking Rate to ensure CRT during maximum range of activity
Verify LV lead integrity through EGM (LV tip/HVA) and pacing threshold

If RV lead impedance is less than 300 ohms, test in RV + LV configuration*
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Model 7272Follow-up Considerations
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
InSync® ICD Model 7272Follow-up Considerations
In Summary
Cardiac Resynchronization therapy offers an adjunctive approach for treating selected patients with ventricular dysynchrony and moderate to severe heart failure who remain symptomatic despite optimal, stable medical therapy.
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Check battery
voltage and
last charge
Check lead
 impedance
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Case Studies
Case Study: Ischemic Cardiomyopathy
57 year-old white male
Ischemic cardiomyopathy
NYHA Class III heart failure
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
The results presented in these case studies are specific to these individual patients. Patient results will vary, not every response is the same.
Courtesy of Dr. Eric Burton, Southwest Florida Heart Group, Fort Myers, Fl
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Courtesy of Dr. Eric Burton, Southwest Florida Heart Group, Fort Myers, Fl
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Courtesy of Dr. Eric Burton, Southwest Florida Heart Group, Fort Myers, Fl
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Case Study: Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
*Patient was enrolled in the initial phase in which patients were randomized for three months
Courtesy of Dr. Eric Burton, Southwest Florida Heart Group, Fort Myers, Fl
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Case Study: Non-Ischemic Cardiomyopathy
71-year-old white female
Idiopathic dilated cardiomyopathy
NYHA Class III heart failure
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Courtesy of Dr. Eric Burton, Southwest Florida Heart Group, Fort Myers, Fl
The data reflected in the third column (12-month evaluation) corresponds to 9-months of cardiac resynchronization therapy for this patient.
Note: This patient was enrolled in the initial 3-month randomization period of the MIRACLE trial. Cross-over occurred and the patient began receiving therapy 3 months post-implant.
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Case Study: Non-Ischemic Cardiomyopathy (continued)
Case Study: Non-Ischemic Cardiomyopathy
Brief Statement for Cardiac Resynchronization System (InSync 8040 Generator / InSync ICD 7272 / Attain Models 2187, 2188, 4193 Leads / 9790/2090 Programmer )
Indications
-          The Medtronic InSync device is indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration greater than or equal to 130ms.  The InSync ICD system is, also, intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmia.
-          The Medtronic Models 9790 and 2090 Programmers are portable, microprocessor-based instruments used to program Medtronic implantable devices.
-          The Attain Left heart leads have application as part of a Medtronic biventricular pacing system.

Contraindications
-          Asynchronous pacing is contraindicated in the presence (or likelihood) of competitive or intrinsic rhythms.
-          Unipolar pacing is contraindicated in patients with an implanted defibrillator or cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of defibrillator or ICD therapy.
·          The InSync ICD is contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, or for patients with incessant VT or VF.
·          The Attain Models 2187, 2188, and 4193 leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
-          Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions
-          Patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation. These may result in underdetection of VT/VF, inappropriate therapy delivery, and/or electrical reset of the device.
-          Certain programming and device operations may not provide cardiac resynchronization.
-          The InSync Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  For this reason, the device should be replaced prior to ERI being set.
-          An implantable defibrillator may be implanted concomitantly with an InSync system, provided implant protocols are followed.
-           Leads, stylets and guide wires should be handled with great care, their use may cause trauma to the heart.  When using a Model 4193 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length).
-          Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development.
-          Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
-          Back-up pacing should be readily available during implant. Use of leads may cause heart block.

See the appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential adverse events.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Cardiac catheterization, Jan 2000 - global hypokinesis with EF 25-30%, normal LV filling pressures.  Luminal coronary atherosclerosis.
Echo, Jan 2000 -  left atrial size 3.6 cm.  Dilated left ventricle with LVEDD 58 mm.  EF 30-35%.  Anterior wall akinetic, no significant valvular abnormalities.
ECG, March 2000 - normal sinus rhythm, left axis deviation, LBBB, QRS 160 msec.
Hyperlipidemia
No indication for pacemaker or ICD; No history of atrial arrhythmias
Courtesy of Dr. David DeLurgio, Crawford Long Hospital, Atlanta, Ga
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Courtesy of Dr. David DeLurgio, Crawford Long Hospital, Atlanta, Ga
Courtesy of Dr. David DeLurgio, Crawford Long Hospital, Atlanta, Ga
4
I
335 meters
16.39 ml/kg/min
478 seconds
39%
160 ms
Able to do daily housework, laundry, cooking, vacuuming without shortness of breath. No limitation in activity and regularly goes dancing.
82
III
259 meters
15.7 ml/kg/min
215 seconds
34%
160 ms
Exertional dyspnea with chest discomfort, extreme fatigue with any exercise, palpitations, 2-pillow orthopnea, paroxysmal nocturnal dyspnea, inability to do housework.
Quality of Life Score
NYHA Class
Six-Minute Walk
Peak VO2
Peak Exercise Time
EF (core lab calc)
QRS Duration
Symptoms

12-Month Evaluation after Implant (March 2001)
Baseline (March 2000)
Cardiac Resynchronization Therapy Results:
Courtesy of Dr. David DeLurgio, Crawford Long Hospital, Atlanta, Ga
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
12-Month Evaluation after Implant (March 2001)
Courtesy of Dr. David DeLurgio, Crawford Long Hospital, Atlanta, Ga
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection
Courtesy of Dr. David DeLurgio, Crawford Long Hospital, Atlanta, Ga
InSync Model 8040
InSync Model 8040

InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272
InSync® ICD Model 7272Header Connection