1. CRM-88604-AA JUN2012 HRS 2012 S-ICD Clinical Highlights

2. CRM-88604-AA JUN2012 Disclaimer The content in this presentation was presented at HRS, May 2012. This presentation is for educational purposes only and should not be copied or presented without the permission of Boston Scientific Corp. Like any other service, in spite of our best efforts the information in this presentation may become out of date over time. Nothing on this presentation should be construed as the giving of advice or the making of a recommendation and it should not be relied on as the basis for any decision or action. The materials are intended for educational purposes only. Boston Scientific neither assumes nor accepts liability for the accuracy or completeness or use of, nor any duty to update, the information contained in this presentation. Some information in this presentation describe products in development that will require approvals or clearances by FDA prior to market release. Some products may be investigational and limited by Federal law to investigational use.

3. CRM-88604-AA JUN2012 Table of Contents 1.Safety and Efficacy of a Subcutaneous Implantable Defibrillator (S-ICD®): HRS Late Breaking Clinical TrialsS-ICD Presented by: Martin C. Burke, DO 2.International Experience with a Subcutaneous ICD; Preliminary Results of the EFFORTLESS S-ICD Registry EFFORTLESS S-ICD Registry Presented by: Pier D. Lambiase, MD, PhD HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

4. CRM-88604-AA JUN2012 Safety and Efficacy of a Subcutaneous Implantable Defibrillator (S-ICD®) HRS Late Breaking Clinical Trials Martin C. Burke, DO Professor of Medicine Interim Chief of Cardiology Director, Heart Rhythm Center University of Chicago Heart Rhythm - May 2012; LB01-6 Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

5. CRM-88604-AA JUN2012 Subcutaneous-ICD System  Designed to sense, detect and treat malignant ventricular tachyarrhythmias  S-ICD System is entirely subcutaneous Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

6. CRM-88604-AA JUN2012 S-ICD Study Design Prospective, Single-Arm Comparison to OPC Enrollment (N=330) 33 Sites in the US, NZ, NL, UK 1 o Efficacy Endpoint: Acute VF Conversion Rate 2 consecutive successes out of 4 attempts Lower Bound of 2-sided CI 95% > 88% Semi-Annual Follow-Up Visits Through Study Close Optional Sub-Study VF Conversion Rate at ≥150 Days 1 o Safety Endpoint: 180-Day System Complication Free Rate Lower Bound of 2-sided CI 95% > 79% Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

7. CRM-88604-AA JUN2012 Eligibility Inclusion  Age ≥ 18 years  Met guidelines for ICD implantation 3 or replacement of an existing ICD system  An appropriate pre-operative ECG Key Exclusion Criteria  Prior VT reliably terminated with anti-tachycardia pacing  Existing epicardial patches or subcutaneous array  Unipolar pacemakers  Severe renal dysfunction (GFR ≤ 29) Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

8. CRM-88604-AA JUN2012 S-ICD System IDE Study Results Burke, S-ICD, HRS 2012, Boston, MA

9. CRM-88604-AA JUN2012 Patient Enrollment Implant Testing Completed EFFECTIVENESS COHORT (N=304) Implant Testing Not Completed (N=17) Active Patients (N=294) Not Discharged with System (N=7) Exits after Hospital Discharge (N=12) Deaths unrelated to device or procedure (N=7) Death unknown due to limited information from overseas death (N=1) Patients Withdrawn PRIOR to Implant (N=9) Implant Attempts SAFETY COHORT (N=321) Patients Enrolled (N=330) Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

10. CRM-88604-AA JUN2012 Basic Patient Demographics Demographic CategoryValue Age (years)52 ± 16 Male74% Height (cm)174 ± 10 Weight (kg)91 ± 25 BMI (kg/m 2 )30 ± 7 Race Caucasian65% African American24% Hispanic or Latino7% Other4% Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

11. CRM-88604-AA JUN2012 Baseline Characteristics AttributeStatistic/Category N=321 n% Co-morbidities History Congestive Heart Failure19761 Hypertension18758 Myocardial Infarction13341 Diabetes9028 Atrial Fibrillation4915 Valve Disease4213 COPD278 Stroke186 Cardiac Surgical History Percutaneous Revascularization9229 CABG4815 TV-ICD4313 Valve Surgery186 Pacemaker41 Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

12. CRM-88604-AA JUN2012 Primary & Secondary Prevention Patient Distribution Similar to NCDR Registry Secondary Prevention 21% Secondary Prevention 22% Primary Prevention 79% Primary Prevention 78% Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

13. CRM-88604-AA JUN2012 Baseline Characteristics AttributeStatistic/Category N=321 n% NYHA Class at Enrollment Class I6821 Class II14645 Class III5517 Class IV1<1 Unknown/Not Assessed5116 Ejection Fraction (%) (n=299) Mean ± SD (Median)36 ± 16 (31) Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

14. CRM-88604-AA JUN2012 Implant Success Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

15. CRM-88604-AA JUN2012 Implant Attempts  321 patients underwent implant procedure  95% implanted using only anatomical landmarks (no medical imaging)  No electrode or pulse generator movement in 99% of implanted patients throughout follow-up period Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

16. CRM-88604-AA JUN2012 Effectiveness Results Primary Effectiveness Endpoint Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

17. CRM-88604-AA JUN2012 Primary Effectiveness Endpoint Analysis Cohort Patients Enrolled (N=330) Patients Withdrawn PRIOR to Implant (N=9) SAFETY COHORT/ Implant Attempts (N=321) EFFECTIVENESS COHORT (N=304) Acute Induction Testing Not Performed (N=1) Acute Induction Testing Non- evaluable (N=16) Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

18. CRM-88604-AA JUN2012 Primary Effectiveness Endpoint Met  Primary IDE Effectiveness Endpoint  Hypothesis: Lower Bound of 2-sided CI 95% >88%  N=304 patients Induction Testing Not Performed Non- Evaluable Patients Evaluable Results Conversion Rate (%) 95% Lower Bound (%) SuccessfulFailure 1163040100.098.8 Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

19. CRM-88604-AA JUN2012 Sensitivity Analysis Exceeds OPC  Primary IDE Effectiveness Endpoint  Hypothesis: Lower Bound of 2-sided CI 95% >88%  Sensitivity Analysis  Failure: Patients w/ incomplete testing and ≥1 failed shock  N=315 patients Induction Testing Not Performed Non- Evaluable Patients Evaluable Results Conversion Rate (%) 95% Lower Bound (%) SuccessfulFailure 1163040100.098.8 153041196.593.8 Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

20. CRM-88604-AA JUN2012 All Analyses Exceed OPC  Primary IDE Effectiveness Endpoint  Hypothesis: Lower Bound of 2-sided CI 95% >88%  Sensitivity Analysis  Failure: Patients w/ incomplete testing and ≥1 failed shock  Worst-Case Sensitivity  All non-evaluable and 1 not tested deemed “Failures”  N=321 patients Induction Testing Not Performed Non- Evaluable Patients Evaluable Results Conversion Rate (%) 95% Lower Bound (%) SuccessfulFailure 1163040100.098.8 153041196.593.8 003041794.791.7 Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

21. CRM-88604-AA JUN2012 Spontaneous Episodes Evaluation VT/VF Episodes TotalDiscreteStorm IDE Study Episodes10928 81 (4 events) Patients16 2 All episodes successfully converted with 80J or spontaneously converted Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

22. CRM-88604-AA JUN2012 Unnecessary Therapy Avoided  Algorithm prevents therapy for VT/VF rhythms that are likely to spontaneously terminate  Therapy avoided in 63% of patients with VT/VF rhythms meeting criteria to charge without any reports of syncope Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

23. CRM-88604-AA JUN2012 Example: Non-Sustained MVT Likely to receive therapy from TV-ICD DURATION: 16 seconds47 cycles Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

24. CRM-88604-AA JUN2012 Safety Results S-ICD System IDE Study Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

25. CRM-88604-AA JUN2012 Safety Results Analysis Cohort Patients Enrolled (N=330) SAFETY COHORT/ Implant Attempts (N=321) Patients Withdrawn PRIOR to Implant Procedure (N=9) Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

26. CRM-88604-AA JUN2012 Primary Safety Endpoint Met Freedom from Type I Complication 180-day Type I Complication-Free Rate: 99.0% (97.9% LCL) Post-op Days 180-day Performance Goal (79%) Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

27. CRM-88604-AA JUN2012 Freedom from all Device-, Labeling-, & Procedure- related Complications 180-day Device & Procedure-related Complication-free Rate: 92.1% (88.9% LCL) Post-op Days 180-day Performance Goal (79%) Freedom from Type I - III Complication Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

28. CRM-88604-AA JUN2012 Safety Results Infections Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

29. CRM-88604-AA JUN2012 Few Infections Led to Explant All Suspected & Confirmed Infections (N=18) Managed w/ antibiotics (n=13) Managed w/ sternal wound revision (n=1) Superficial or Incisional Infections Managed without System Explant (n=14, 4.4%) System Explanted (n=4, 1.3%) Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

30. CRM-88604-AA JUN2012 Infections: Study-Wide Learning on Surgical Prep Infections requiring explant 40 All 4 infections requiring explantation occurred early in study enrollment ENROLLMENTS Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

31. CRM-88604-AA JUN2012 Safety Results Inappropriate Shocks Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

32. CRM-88604-AA JUN2012 Inappropriate Shocks  38 patients* experienced shocks due to non-VT/VF event  15 patients:SVT > Discrimination zone  24 patients:Oversensing  Rate of inappropriate therapy is consistent with current transvenous ICDs  No patients experienced a shock due to discrimination error in Conditional Shock (dual) zone * 1 patient experienced multiple events Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

33. CRM-88604-AA JUN2012 Dual-zone Programming Reduced Inappropriate Shocks 54% relative reduction 74% relative reduction Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

34. CRM-88604-AA JUN2012 International Experience with a Subcutaneous ICD; Preliminary Results of the EFFORTLESS S-ICD Registry PD Lambiase DAMJ Theuns, C Barr, R Knops, F Murgatroyd, JB Johansen & L Boersma on behalf of the EFFORTLESS S-ICD investigators Heart Rhythm - May 2012; Vol 9:5(S1-33) AB07-2. Sponsor: Cameron Health, Inc. San Clemente, CA Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

35. CRM-88604-AA JUN2012 The S-ICD System Operation Single-zone programming allows therapy to be delivered solely on measured heart rate Dual-zone programming activates SVT discrimination algorithm to determine appropriateness of therapy S-ICD System is entirely subcutaneous and can be placed using anatomical landmarks Three sensing vectors to identify most robust cardiac signal Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

36. CRM-88604-AA JUN2012 Evaluation oF FactORs AffecTing the CLinical Outcome and Cost EffectiveneSS of the S-ICD – The EFFORTLESS S-ICD Registry Design International, standard of care Registry to collect short, mid and long-term operational and clinical outcome data on the Cameron Health S-ICD system 5 year data post implant Retrospective and prospective patients implanted since CE mark Aiming to recruit up to 1000 patients Centers to be included from all current commercial countries Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

37. CRM-88604-AA JUN2012 The EFFORTLESS Registry Design Protocol includes Documentation of system related outcomes and clinical events Prospective, Quality of Life sub-study to assess patients perception of their therapy Run by Tilburg University Core Lab- Professor Susanne Pedersen SF-12, FPAS, ICDC, HADS, DS-14 & EQ-5D QOL questionnaires Baseline, 3, 6, 12 months post implant Direct comparison to TV therapy via MIDAS study cohort Cost effectiveness analysis by hospital resource tracking and use of EQ-5D questionnaire Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

38. CRM-88604-AA JUN2012 EFFORTLESS Registry Inclusion/Exclusion Criteria Inclusion Criteria ≥ 18yrs* at time of consent Eligible for implantation of an S-ICD system per local clinical guidelines or currently implanted with an S-ICD Exclusion Criteria Participation in any other investigational study that may interfere with interpretation of the study results VT that is reliably terminated by ATP Unipolar pacemakers *Not applicable for centers enrolling under DN 15677, August 30, 2010 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

39. CRM-88604-AA JUN2012 EFFORTLESS Registry Site Participation in 9 Geographies UK (13) NL (7) DK (3) SL(1) CZ (3) I (4) P (1) DE (10) NZ (2) Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

40. CRM-88604-AA JUN2012 EFFORTLESS Registry Recruitment Overview NL (123) UK (75) CZ (17) DK (14) NZ (1) 230 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

41. CRM-88604-AA JUN2012 EFFORTLESS Registry Patient Status as of April 27, 2012 Average FU 389±282 days, max 981 days Active Patients (N =210 ) Withdrawn N=1 (heart transplant) Deaths N=6* Explants N=5 Inactive N=1 Missing Data N=4 Withdrawn due to ineligibility N=2 Consented not implanted N=1 Patients Implanted (N =223) Patients Enrolled (N=230) * No device related deaths Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

42. CRM-88604-AA JUN2012 EFFORTLESS Registry Basic Patient Demographics Demographic CategoryValueN Age (yrs; range)49±19* (11-86)227 Male (%)74227 Height (cm)175±10186 Weight (kg)81±20196 LVEF (%; median)42±19 (35)178 QRS (ms)104±21207 *Approx. 60% of patients (131/227) ≥ 50 yrs Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

43. CRM-88604-AA JUN2012 EFFORTLESS Registry Standard ICD Baseline Characteristics AttributeStatistic/Category N=223 % Co-morbidities Congestive Heart Failure32 Hypertension25 Myocardial Infarction38 Diabetes13 Renal Disease10 Atrial Fibrillation19 COPD6 Stroke4 Cardiac Surgical History Ablation7 CABG10 Valve Surgery6 Prior TV ICD15* Pacemaker3* 37 patients had previously implanted systems- 6 patients have concomitant PM/S-ICD Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

44. CRM-88604-AA JUN2012 EFFORTLESS Registry Heart Failure & Indication Characteristics AttributeStatistic/Category N=70 n% NYHA Class at Enrollment Class I1927 Class II3246 Class III1014 Class IV00 Unknown/Not Assessed913 Indicationn% Primary14464 Secondary8136 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

45. CRM-88604-AA JUN2012 EFFORTLESS Registry Broad Range of ICD Indications Patients from a broad range of indications have received the S-ICD Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

46. CRM-88604-AA JUN2012 EFFORTLESS Registry Cardiac Medications at Enrollment Medicationn% Amiodarone 157 Diuretics 9341 ACE Inhibitors 9341 Beta Blockers 15167 Digoxin 115 Lipid Lowering (incl. statins) 4821 None3315 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

47. CRM-88604-AA JUN2012 Registry Results Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

48. CRM-88604-AA JUN2012 EFFORTLESS Registry Effective Conversion of Induced VT/VF Patient Datan% Implant Conversion test data available204 Successful conversion within 1 procedure -Successful at 65J -Successful at  80J 201 197 201 98.5 Patients requiring repositioning -Successful conversion following repositioning -Awaiting retesting (non inducible) 1212 1.5 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

49. CRM-88604-AA JUN2012 0 5 10 15 20 25 30 35 40 <1212-14.915-17.918-20.921-23.9 ≥24 Seconds % of Events 93% <21 seconds N=86* Mean ± SD:15.9±3.8 Median:15.0 3.5% 37.2% 34.9% 17.4% 3.5% *No data available for retrospective patients EFFORTLESS Registry 93% of Events Treated in < than 21secs Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

50. CRM-88604-AA JUN2012 Discrete EpisodesPatients EPISODES Type II spontaneous Termination 1 st S-ICD System Shock Conversion 2 nd S-ICD System Shock Conversion 16112131 Storm EventsEpisodesPatients EPISODES S-ICD System Shock Conversion 432232 (100%) EFFORTLESS Registry 100% Conversion of Spontaneous VT/VF 16 discrete VT/VF episodes from 11 patients 32 VT/VF storm episodes from 2 patients both with electrolyte imbalances (post dialysis and post surgery) Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

51. CRM-88604-AA JUN2012 EFFORTLESS Registry Annual Inappropriate Shock Rate of 7% 0 5 10 15 20 Rate > Shock Zone Oversensing Percent 7% 15 patients received inappropriate shocks (7%) No inappropriate shocks have been recorded for AF/SVT within a programmed conditional shock zone Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

52. CRM-88604-AA JUN2012 EFFORTLESS Registry Appropriate vs. Inappropriate Episodes 0 10 20 30 40 50 60 AppropriateInappropriateEpisode not stored Episodes (67%) (28%) Total of 72 Episodes Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

53. CRM-88604-AA JUN2012 EFFORTLESS Registry Clinical Event Definitions Clinical Event Any untoward medical occurrence Categories Complications: Invasive intervention required Observations: Conservative therapy required Type I-III Clinical Events Device-, labeling-, or procedure-related Type IV Clinical Events Related to patient condition Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

54. CRM-88604-AA JUN2012 EFFORTLESS Registry Device & Procedure-Related Events CategoryComplicationsObservations Device-related (Type I)216 Labeling-related (Type II)00 Procedure-related (Type III)1519 17 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

55. CRM-88604-AA JUN2012 EFFORTLESS Registry Device-Related Events - Type I CategoryComplicationsObservations Inappropriate Shock - oversensing114 Discomfort01 Premature battery depletion10 Inability to communicate with device01 Total216 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

56. CRM-88604-AA JUN2012 EFFORTLESS Registry Procedure-Related Events - Type III CategoryComplicationsObservations Infection/suspicion of infection62 Inappropriate Shock - rate > shock zone 15 Suboptimal electrode position50 Hematoma12 Redness/irritation03 Discomfort02 Keloid formation01 Phantom shocks/vibration03 Transfusion10 PG Movement/Revision10 Total1519 Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

57. CRM-88604-AA JUN2012 EFFORTLESS Registry Infection Management All Suspected Infections* (N=8) Medically Managed without System Explant (n=3, 1.3%) System Explanted (n=4, 1.8%) Electrode Explanted (n=1, 0.4%) Electrode Re-implant (n=1) S-ICD Re-implant (n=1) *No reported endocarditis or blood born infection Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.