ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM.

{0} # Summary of Safety and Effectiveness ## P970024 *** ## Angeion Corporation Sentinel™ Implantable Cardioverter Defibrillator (ICD) System and AngeFlex™ Transvenous Defibrillation Lead System *** Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Cardiovascular and Respiratory Devices 8 {1} # TABLE OF CONTENTS 1.0 General Information ... 3 2.0 Indications for Use ... 3 3.0 Contraindications ... 3 4.0 Warnings and Precautions ... 4 5.0 Device Description ... 4 5.1 The Sentinel ICDs ... 4 5.1.1 Sensing and Detection ... 5 Table 1: Low Zone Detection ... 5 Table 2: High Zone Detection ... 5 5.1.2 Therapy ... 6 Table 3: Low Zone Therapy ... 6 Table 4: High Zone Therapy ... 7 Non-Invasive Programmed Stimulation (NIPS) ... 7 Coupled Shock Induction (Models 2010, 2011 and 2012 only) ... 7 Defibrillation Waveforms ... 7 5.1.3 Diagnostics ... 8 Table 5: Stored Information ... 8 5.2 Sentinel Programming Systems ... 8 5.3 Defibrillation Test Systems ... 9 5.4 Lead Systems ... 9 6.0 Alternative Practices and Procedures ... 9 7.0 Marketing History ... 9 8.0 Adverse Events ... 9 8.1 Clinical Observations ... 10 Table 6: Summary of Clinical Observations ... 10 8.2 Clinical Complications ... 11 Table 7: Summary of Clinical Complications ... 11 8.3 Potential Adverse Events ... 11 8.4 Potential Psychological Events ... 12 9.0 Summary of Pre-Clinical Studies ... 12 Table 8: Summary of testing performed for sub-assembly and assembly levels, biocompatibility tests, and animal studies ... 12 9.1 Sentinel ICD Component Bench Tests ... 14 9.2 Sentinel ICD/System Bench Tests ... 14 9.3 Lead System and Accessory Bench Tests ... 15 9.4 Biocompatibility Studies ... 15 9.5 Animal Studies ... 15 10.0 Clinical Study ... 16 10.1 Objectives ... 16 10.2 Patient Population and Gender Bias Analysis ... 16 10.2.1 Sentinel ICD System Study Patients ... 16 Table 9: Description of Sentinel ICD System Patient Population ... 17 10.2.2 Gender Bias Analysis ... 17 10.3 Study Design ... 18 10.4 Clinical Results ... 18 10.4.1 Statistical Analysis ... 18 10.4.2 Induced and Spontaneous Arrhythmia Episode Experience ... 18 Table 10: Arrhythmia Conversion ... 18 10.4.3 Patient Survival ... 19 Table 11: Safety Results ... 19 10.4.4 Clinical Events (Observations and Complications) ... 19 10.4.5 Device Accountability, Reliability, and Longevity ... 19 Table 12: Device Accountability ... 19 11.0 Conclusions Drawn from the Studies ... 20 12.0 Panel Recommendation ... 20 13.0 FDA Decision ... 20 14.0 Approval Specifications ... 20 Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 2 {2} # 1.0 General Information Device Name: Implantable Cardioverter Defibrillator Device Trade Name: Angeion® Sentinel™ Implantable Cardioverter Defibrillator (ICD) System Models 2000/2010/2011/2012 and the Angeion AngeFlex™ Transvenous Defibrillation Lead System Models 4020/4021/4022/4023 Applicant’s Name/Address: Angeion Corporation 7601 Northland Drive Minneapolis, Minnesota 55428-1088 Dates of Panel Recommendation: None Premarket Approval Application (PMA) Number: P970024 Date of Good Manufacturing Practice Inspection: February 12, 1997 (sterilizer), June 24, 1997, and April 8, 1998 Date of Notice of Approval to Applicant: August 19, 1998 # 2.0 Indications for Use The Angeion® Sentinel™ Implantable Cardioverter Defibrillator (ICD) System Models 2000/2010/2011/2012 and the Angeion AngeFlex™ Transvenous Defibrillation Lead System Models 4020/4021/4022/4023 (hereinafter called the Sentinel ICD System) is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia - Recurrent, poorly tolerated, sustained ventricular tachyarrhythmia NOTE: The clinical outcome for hemodynamically stable VT patients is not fully known. Safety and effectiveness studies have not been conducted. # 3.0 Contraindications The Sentinel ICD System is contraindicated for patients who have: - Ventricular tachyarrhythmias that have demonstrated a reversible cause such as digitalis intoxication, electrolyte imbalance, drug induced hypoxia, sepsis, or a transient cause attributable to such factors as acute myocardial infarction, electrocution, or drowning. - A unipolar pacemaker, or a pacemaker that defaults to unipolar mode. Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 3 {3} The ICD may also be contraindicated for patients who have: - Uncontrolled supraventricular tachyarrhythmia (SVT) and excessive ventricular rates despite conventional drug therapy. Depending on the programming detection criteria, SVT may cause therapy delivery. - Ventricular tachyarrhythmias that require frequent shocks. Frequent shocks may cause intolerable patient discomfort and the ICD batteries to deplete more rapidly than is acceptable. The Programming Head, Test Electrode, and Patient Cable are contraindicated for use with any device other than the Sentinel ICD or Defibrillation Test System (DTS), or with any external stimulators that do not meet electrical specifications for the non-invasive programmed stimulation (NIPS) interface. Lead use is contraindicated for those patients with tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue). ## 4.0 Warnings and Precautions See attached labeling. ## 5.0 Device Description The Sentinel ICD System and the AngeFlex Defibrillation Lead System consist of the following: Sentinel ICD System - Sentinel ICD Models 2000, 2010, 2011 and 2012; System Programmer Models 3002 and 3007; External Printer Model 3008; Smart Wand™ Programming Head Model 3003; Defibrillation Test System (DTS) Models 7001 and 7002; Test Electrode Model 5007; and, Patient Cable Models 5006 and 5020; AngeFlex Transvenous Defibrillation Lead System - AngeFlex Transvenous Defibrillation Lead Models 4020, 4021, 4022 and 4023; any commercially available active fixation bipolar pace/sense leads; Model 5009 Defibrillation Lead Adapter; and accessories - Models 5015 defibrillator magnet, 5025 defibrillator torque wrench/setscrews, 5026 mineral oil, 5027 port plugs, 5029 medical adhesive, 5030 vein picks/lead caps, 5032 AngeFlex suture sleeves, 5033 suture sleeves (10 Fr), 5034 stylet (69 cm), and 5035 stylet (58 cm). ## 5.1 The Sentinel ICDs The Sentinel ICDs are battery-operated devices capable of detecting and treating episodes of bradycardia and tachycardia. The Sentinel ICDs are fully programmable, two-zone, tiered therapy devices that incorporate antitachycardia pacing (ATP), cardioversion, and defibrillation tachyarrhythmia therapies and bradycardia pacing support (VVI mode). In addition, the can of the Sentinel ICD may be programmed to serve as a Hot Can™ electrode. The Sentinel ICD circuitry is contained in a hermetically sealed titanium can and consists of discrete electrical components, hybrid circuit assemblies, the ASEC™ dual battery system, Small Cap™ high voltage capacitors, and a telemetry antenna. The header is made of polyurethane and provides electrical connection to the pacing and defibrillation leads. The headers on the Models 2000/2010 Sentinel ICDs are identical and accept two DF-1 compatible lead ends for high voltage defibrillation and two IS-1 lead compatible ends for pacing and sensing. The header on the Model 2011 accepts one DF-1 and one IS-1 lead connector. The IS-1 and DF-1 are international Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 4 {4} standards for lead-to-pulse generator connection. The Model 2012 Sentinel ICD accepts two 6.1 mm defibrillation leads and two 4.75 mm pace/sense lead connectors. The Sentinel ICDs range in weight from approximately 108 to 110 grams with a volume of 58 to 61 cubic centimeters. ## 5.1.1 Sensing and Detection There are two tachyarrhythmia detection and therapy zones for the Sentinel ICD: Low Zone and High Zone. (Please refer to Table 1 for the programmable parameters of the Low Zone and to Table 2 for the programmable parameters of the High Zone.) The Low Zone detects and treats lower rate tachyarrhythmias, while the High Zone detects and treats higher rate tachyarrhythmias. The detection boundaries for both of these zones are based upon pre-programmed criteria determined by the user. Once the Sentinel ICD has detected an arrhythmia, it can deliver therapy from that zone of detection (the Sentinel ICD can also be programmed with Tachy Therapy "OFF", or be programmed to monitor, detect, and record arrhythmias without delivering therapy). Detection of a tachyarrhythmia is an algorithmic process which monitors the combination of tachyarrhythmia rate presenting itself in a detection zone, and the continuation of the tachyarrhythmia (duration) in the zone. An appropriate response is then processed. Detection can occur in only one zone, and is the means by which a specific programmed therapy will be selected. Table 1: Low Zone Detection | Parameter | Description | Programmability | | --- | --- | --- | | Low Zone Rate | If the heart rate meets or exceeds this setting, the ICD recognizes a Low Zone arrhythmia | 100 to 245 bpm in steps of 5 | | Low Zone Duration | Determines how many cardiac cycles are required to occur in the Low Zone before the ICD can prepare and deliver Low Zone therapy | 4 to 100 cycles in steps of 2 | | Low Zone Counter Reset (Models 2010, 2011 and 2012 only) | When this Low Zone parameter is met, the Low Zone and Boundary Zone counts are reset to 0 | 1 or 2 consecutive cycles | | Sudden Onset | Provides additional assessment criteria for tachycardias occurring in the Low Zone | On or Off | | Sustained High Rate (minutes) | Determines the length of time a gradual inception arrhythmia is allowed to continue by providing a programmable time limit to the Sudden Onset's therapy inhibition | • Infinite • 0.5 to 29 minutes in steps of 0.5 min. • 30 to 60 minutes in steps of 2 min. (30 minutes max. for Model 2000) | | Boundary Zone | Extends 10 bpm above and below the programmed High Zone rate | Non-programmable | Table 2: High Zone Detection | Parameter | Description | Programmability | | --- | --- | --- | | High Zone Rate | If the heart rate meets or exceeds this setting, the ICD recognizes a High Zone arrhythmia | 105 to 250 bpm in steps of 5 bpm | | High Zone Duration | If the number of High Zone cardiac cycles meets this parameter value, the ICD prepares High Zone Therapy (depending on Boundary Zone count). | 4 to 30 cycles in steps of 2 cycles | | High Zone Counter Reset (Models 2010, 2011 and 2012 only) | When the High Zone parameter is met, the High Zone and Boundary Zone counts are reset to 0 | 1 or 2 consecutive cycles | | Boundary Zone | Extends 10 bpm above and below the programmed High Zone rate | Non-programmable | In addition, High Zone detection can occur when 12 of the previous 16 R-R intervals reflect a rate at or above the High Zone rate. Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System {5} Once an arrhythmia has been detected in either the Low Zone or High Zone, the Sentinel ICD can prepare and deliver an appropriate therapy. The Sentinel ICD is capable of delivering a sequence of therapies for both zones. If an arrhythmia is redetected following delivery of the first therapy (Therapy 1), a second therapy (Therapy 2) may be prepared and delivered originating from the zone of re-detection (a therapy will not be delivered from the Low Zone if a High Zone therapy has already been delivered in the episode). The Sentinel ICD will deliver up to five therapies to treat a single arrhythmia episode. If the arrhythmia has not been terminated after five therapies have been delivered (from either the Low or High Zones), the Sentinel ICD will cease to deliver therapy. The Sentinel ICD resumes normal detection and therapy if the cardiac rate drops below the Low Zone rate for more than 20 consecutive cycles. ## 5.1.2 Therapy Therapy for the Sentinel ICD is organized into Low Zone Therapy and High Zone Therapy. In addition, induction is available through use of Non-Invasive Programmed Stimulation (NIPS); and Coupled Shock Induction. Low and High Zone Therapy parameters are described in Tables 3 and 4. Table 3: Low Zone Therapy | Therapy | Description | Programmability | | | --- | --- | --- | --- | | THERAPY 1: Anti-Tachy Pacing (ATP) | Therapy consisting of one or more bursts of a sequence of pacing pulses. ATP employs adaptive, interval decremental, overdrive pacing with pulse count increment. | Parameter • Initial # of Pulses • Coupling Interval (%) • Ramp Decrement • Number of Bursts • Coupling Interval Decrement (Models 2010, 2011 and 2012 only) | Option(s) • 1 to 15, in steps of 1 • 60 to 95, in steps of 5 • 0 to 40 ms in steps of 2 ms • 1 to 10 in steps of 1 • 0 to 40 ms in steps of 2 | | Cardioversion | Termination of a tachyarrhythmia by a shock delivered in a 2 ms monophasic pulse simultaneous with a sensed cardiac event (if no cardiac activity is detected by the end of one second, the ICD will deliver the shock asynchronously at that time). | 0.27, 0.6, 1.0, 1.6, 2.4, 3.3, 4.3 (joules) | | | Defibrillation Shock | Termination of a tachyarrhythmia by a monophasic or biphasic shock (depending on the selected waveform parameter) delivered simultaneously with a sensed cardiac event (if no cardiac event is detected by the end of one second, the ICD delivers the shock asynchronously at that time). | 0.1, 0.9, 2.9, 4.2, 5.8, 7.6, 9.6, 11.8, 14.3, 17.1, 20.0, 23.2, 26.7 (joules) | | | THERAPY 2: Cardioversion | See description above. | Same parameters as above. | | | Defibrillation Shock | See description above. | Same parameters as above. | | | THERAPIES 3-5: Defibrillation Shock | See description above. | 26.7 joules, non-programmable | | Table 4: High Zone Therapy | Therapy | Description | Programmability | | --- | --- | --- | | THERAPY 1: | | | Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 6 {6} | Defibrillation Shock | Termination of a tachyarrhythmia by a monophasic or biphasic shock (depending on the selected waveform parameter) delivered simultaneous with a sensed cardiac event (if no cardiac event is detected by the end of one second, the ICD delivers the shock asynchronously at that time). | 0.1, 0.9, 2.9, 4.2, 5.8, 7.6, 9.6, 11.8, 14.3, 17.1, 20.0, 23.2, 26.7 (joules) | | --- | --- | --- | | THERAPIES 2-5: Defibrillation Shock | See description above. | 26.7 joules, non-programmable | Prior to delivery of a cardioversion or defibrillation shock, the Sentinel ICD capacitors are charged based upon the therapy to be delivered. The charging period depends on the therapy energy level and battery status. It varies from less than one second to approximately nine seconds at Beginning-of-Life (BOL), 24 seconds at Elective-Replacement-Indicator (ERI), and 32 seconds at End-of-Life (EOL). Periodically, the Sentinel ICD capacitors are automatically charged to maintain proper device operation. This ensures optimum function of the capacitors and occurs according to an automatic schedule. In addition, the Sentinel ICD is capable of delivering the following types of therapies: ## Non-Invasive Programmed Stimulation (NIPS) NIPS is a method of inducing tachyarrhythmias through the leads system using an external stimulator (pacing) device (i.e. EP stimulator or external pulse generator) to command Sentinel ICD pulses. These external stimulators are connected directly to the cable of the Smart Wand programming head, delivering NIPS to the patient. The external stimulator sends a pulse to the Smart Wand which then sends a telemetry command to the Sentinel ICD. This causes the Sentinel ICD to provide a 2 ms pacing pulse (successive pulses can follow at intervals as short as 20 ms). ## Coupled Shock Induction (Models 2010, 2011 and 2012 only) Coupled shock allows the physician the option of having the Sentinel ICD deliver a programmed, low-energy shock that is delayed from a sensed R wave by a programmable time delay coupling interval to coincide with a T wave. The delivery of a coupled shock is commanded via telemetry through the system programmer and Smart Wand programming head. Defibrillation energy values for coupled shock induction can be programmed to: 0.1, 0.4, 0.9, 1.9, 2.9 and 4.2 (joules). Time delays can be selected to 0 ms, or 50 to 500 ms in steps of 10 ms. Coupled shock is used to intentionally induce fibrillation for patient evaluation. ## Defibrillation Waveforms All defibrillation shocks delivered by the Sentinel ICD are in a selected waveform. The physician is able to select either a Monophasic or Biphasic defibrillation pulse: - Monophasic - An exponential waveform truncated 1.6 ms after 44% tilt is reached. - Biphasic - A two-phase pulse (the monophasic pulse and a pulse of the opposite polarity) with a 0.5 ms delay between phases. Monophasic and Biphasic defibrillation energy values are a function of capacitor voltage and stored energy value. Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 7 {7} # 5.1.3 Diagnostics The Sentinel ICD is capable of storing information, including diagnostic information, in memory and retrieving it for analysis by the user. The types of stored diagnostic information are as follows: Table 5: Stored Information | Element | Description | | --- | --- | | Event History | The ICD stores events that comprise a tachyarrhythmia episode. The ICD stores up to 128 tachyarrhythmia events (50 events for Model 2000) in the ICD's memory. Event History can be reviewed and printed through the programmer. | | EOM and Marker Data | The ICD can be programmed to record segments of EOM and Marker data associated with tachyarrhythmia episodes. This function can be programmed to three settings: Off; On with ATP; On without ATP. Stored Electrograms are available only with ICD Models 2010, 2011 and 2012 (not available with Model 2000). | | Counters (Patient History) | The ICD stores information on the following events: • Non-Sustained Tachy Episodes • ATP Attempts • ATP Successes • Shock Attempts • Shock Successes • Non-Committed Shock Aborts • Programmer Therapy Shocks • Programmer Induction Shocks (2010, 2011, 2012 only) • Capacitor Reform Charges The ICD stores Resettable Counters (which can be reset using the programmer) and Lifetime Counters (permanently stored in the ICD) | | Non-Sustained Activity | When a tachyarrhythmia begins but is not sustained for a sufficient number of intervals to be considered an episode, it is recorded by the ICD as a non-sustained episode. | | Shock Lead Impedance | Shock lead impedance is the effective resistance of the patient lead system to the defibrillation shock current. The programmer will display the current shock lead impedance (from the Data Options Menu) to a maximum of 243 ohms. | | ICD Battery Status | The ICD stores information on the battery status, including battery voltage and battery level (these are displayed by the programmer). Under battery level, the programmer will indicate if the voltage is “OK,” if Elective Replacement Indicator (ERI) is reached, or if End-of-Life (EOL) is reached. | | ICD Status | The ICD stores a record of status messages in memory with information about its operation, stamped with system date and time. The ICD can save up to 14 status messages. | | Patient Information | The ICD stores six blocks of patient information, including two designated for patient name and identification number. The remaining four may be used to record any information the user may require. | # 5.2 Sentinel Programming Systems The Sentinel ICD System consists of the Models 3002 and 3007 Programmers with an off-the-shelf Model 3008 External Printer and the Model 3003 Smart Wand that interrogate and program the Sentinel ICD and DTS devices using radio frequency telemetry. The Programmers are IBM-compatible, off-the-shelf laptop computers that are loaded at Angeion, with Angeion custom designed software for communicating with the Sentinel ICD and the DTS devices. The Model 3002 Programmer uses an Intel 486SX 33MHz processor with standard 4MB of RAM and 120MB or 200MB hard drive. The Model 3007 uses an Intel 100 MHz Pentium processor with 8 MB of RAM (expandable to 40 MB) and 810 MB hard drive. # 5.3 Defibrillation Test Systems The Models 7001 and 7002 DTS consist of identical D-cell (8) battery powered hardware boxes that are designed to facilitate implant testing of the Sentinel ICD. The DTS provides connections between the patient, Model 5007 Test (can) Electrode and leads using the Models 5006 and 5020 Patient Cables. The Models 7001 and 7002 DTS differ only by software, where only the Model Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System {8} 7002 employs coupled shock induction capability. The DTS consists of a plastic box housing and two printed circuit boards (indicator board and the main board), and weighs approximately eight pounds with batteries installed. The DTS also has a rescue button that, if needed, is capable of delivering a 40 joule rescue shock. ## 5.4 Lead Systems The AngeFlex Transvenous Defibrillation Lead is available in four models 4020/4021/4022/4023. The four models are constructed using identical materials and processes, and differ only in overall length and electrode spacing. The two lengths of electrode spacing (13 and 17 cm) are measured from the distal end of the lead to the distal end of the Superior Vena Cava (SVC) electrode. This is designed to offer the physician optional lengths based upon patient anatomy. All lead models have both a Right Ventricle (RV) and SVC shocking electrode and are designed to connect to the Sentinel ICD using DF-1 connectors. In addition, the Model 5009 Defibrillation Lead Adapter can be used to connect a 6.1mm lead to the DF-1 connector of the Sentinel ICD. ## 6.0 Alternative Practices and Procedures Alternative therapies for the treatment of life threatening ventricular arrhythmias, as deemed appropriate by the physician based upon electrophysiology testing and other diagnostic evaluation include the use of antiarrhythmic drugs, ablation and cardiac surgery, and the use of devices including commercially available pacemakers and ICDs. ## 7.0 Marketing History The Sentinel ICD System has been commercially distributed in the European Union as a CE-Marked product since April 17, 1996. Approximately 70 Sentinel ICD Systems have been distributed throughout Germany, United Kingdom, and Italy. The Sentinel ICD System has not been withdrawn from marketing for any reason relating to the safety and effectiveness of the device. ## 8.0 Adverse Events The Sentinel ICD System clinical investigation involved 143 devices implanted in 138 patients with 1130 cumulative implant months (mean implant duration was 8 months). The Sentinel ICD System was evaluated using the AngeFlex Transvenous Defibrillation Lead System Models 4020/4021/4022/4023, the AngePass Defibrillation Lead System 4040/4080 Series, the Endocure 1500 Series Defibrillation Lead System, or a market approved chronic defibrillation lead system. The 66 observations and 8 complications presented in the tables that follow reflect the reported clinical events and experience with the Sentinel ICD System (see Tables 6 and 7). There were eight patient deaths reported during the clinical investigation; these were not attributed to the function or use of the Sentinel ICD System. Rates of occurrence of observations and complications reported in the Sentinel ICD System study were similar to the rates of adverse events experienced by other manufacturers with similar products. ## 8.1 Clinical Observations Table 6: Summary of Clinical Observations Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 9 {9} All patients treated: Sentinel ICD series (N = 138 patients), AngeFlex Defibrillation Lead Systems (N = 70 patients), Endocure lead system (N = 56), AngePass lead system (N = 4) and chronic lead systems (N = 8). Sixty-six observations occurred in a total of 40 patients, some of whom had multiple events. (Total Device Months = 1130) | Event | Number of Events | Number of Patients | Incidence Rate: # Events # Device Months | | --- | --- | --- | --- | | System Related (27) | | | | | ICD Reprogramming/Medication Change | 10 | 10 | 0.009% | | ICD Reprogramming | 9 | 9 | 0.008% | | Appropriate Defib Shock Patient Follow-Up | 1 | 1 | 0.001% | | DTS Extended Induction Time | 1 | 1 | 0.001% | | High Pacing Thresholds | 3 | 3 | 0.003% | | Endocure/AngeFlex Stylet Incompatibility | 1 | 1 | 0.001% | | ICD header/lead incompatibility | 1 | 1 | 0.001% | | Inappropriate Shock Therapy | 1 | 1 | 0.001% | | Other Observations (39) | | | | | Cardiovascular Medication Change | 11 | 10 | 0.010% | | Witnessed Phantom Shock | 2 | 1 | 0.002% | | Abdominal Discomfort | 1 | 1 | 0.001% | | GI Pain, Deemed to be Severe Constipation | 1 | 1 | 0.001% | | CHF | 5 | 5 | 0.004% | | Palpitations | 1 | 1 | 0.001% | | Mitral Valve Replaced | 1 | 1 | 0.001% | | GI Bleed | 2 | 2 | 0.002% | | CVA | 1 | 1 | 0.001% | | Thrombophlebitis | 1 | 1 | 0.001% | | Pneumonia | 2 | 2 | 0.002% | | Cardioversion (external) for AF | 1 | 1 | 0.001% | | Sepsis | 1 | 1 | 0.001% | | Dysphagia | 1 | 1 | 0.001% | | Incision Pain | 1 | 1 | 0.001% | | Ablation | 3 | 3 | 0.003% | | Pacemaker Implant | 3 | 3 | 0.003% | | Prostate Cancer/Device turned off | 1 | 1 | 0.001% | | Total | 66 | 40 | 0.058% | Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 10 {10} Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 11 # 8.2 Clinical Complications ## Table 7: Summary of Clinical Complications All patients treated: Sentinel ICD series (N = 138 patients), AngeFlex Defibrillation Lead Systems (N = 70 patients), Endocure lead system (N = 56), AngePass lead system (N = 4), and chronic lead systems (N = 8). Eight complications were reported in 7 patients. (Total Device Months = 1130). Complications, defined as reported events which require invasive resolution, are presented below. | Complications | Status | Number of Events (E), N = 8 | Incidence Rate (% E/Device Months) | | --- | --- | --- | --- | | ICD repositioning due to discomfort. (Submuscular to Subcutaneous) | Resolved | 1 | 0.001 | | Lead/ICD reconnection after pocket closure due to inappropriate sensing. | Resolved | 1 | 0.001 | | Lead repositioned due to high pacing threshold. | Resolved | 1 | 0.001 | | ICD explanted due to inappropriate sensing. ICD replaced. | Resolved | 1 | 0.001 | | Lead/ICD explanted due to inappropriate sensing. ICD/ Pace/Sense lead replaced | Resolved | 1 | 0.001 | | ICD/Adapters explanted due to noise from damaged epicardial leads. ICD replaced. | Resolved | 1 | 0.001 | | ICD explanted due to inappropriate sensing. ICD replaced. | Resolved | 1 | 0.001 | | ICD explanted due to low battery voltage caused by 10 μF ceramic capacitor leakage. ICD replaced. | Resolved | 1 | 0.001 | # 8.3 Potential Adverse Events Physical patient complications related to the use of an ICD include, but are not limited to, the following: - Acceleration of arrhythmias - Air embolism - Bleeding - Body rejection phenomenon - Chronic nerve damage - Erosion - Excessive fibrotic tissue growth - Extrusion - Fluid accumulation - Formation of hematomas or cysts - ICD electrical and mechanical complications - Inappropriate shocks - Infection - Keloid formation - Lead abrasion - Lead discontinuity - Lead migration/dislodgment - Myocardial damage - Pneumothorax - Shunting current or insulating myocardium during defibrillation with internal or external paddles - Potential mortality due to inability to defibrillate or pace - Thromboemboli - Venous occlusion - Venous or cardiac perforation {11} Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 12 # 8.4 Potential Psychological Events Psychological patient complications related to the use of an ICD system include, but are not limited to: - Dependency - Depression - Fear of premature battery depletion - Fear of losing shocking therapy capability - Fear of shocking while conscious - Fear of device failure - Fear of another person being injured, during physical contact, if the device discharges - Imagined shocking # 9.0 Summary of Pre-Clinical Studies The qualification of the Sentinel ICD System included: bench testing of components, devices, accessories; system level studies (including hardware and software testing); biocompatibility studies; and, animal studies. Table 8 is a summary of these tests; "Pass" denotes that the test results met the company's device specifications. Table 8. Summary of testing performed for sub-assembly and assembly levels, biocompatibility tests, and animal studies | Test Performed | Number of Samples | Test Result | | --- | --- | --- | | ICD Sub-Assembly / Assembly Level: | | | | H-Bridge Hybrid Qualification Report | 28 | Pass | | Power Source, Li SVO Battery Assembly | 13 | Pass | | Transformer, Toroid Qualification Report | 15 | Pass | | Implantable Defibrillator Circuit Board #1 Qualification Report | 5 | Pass | | Implantable Defibrillator Circuit Board #2 Qualification Report | 5 | Pass | | Implantable Defibrillator Circuit Board #3 Qualification Report | 5 | Pass | | Implantable Defibrillator Flex Circuit Board Qualification Report | 5 | Pass | | Flex-Stack Qualification Report | 15 | Pass | | Implantable Defibrillator Antenna Qualification Report | 3 | Pass | | Implantable Defibrillator Circuit Board #3 Qualification Report, Model 2010 | 5 | Pass | | Test Report, Four-Port Header, Model 2010 Insertion and Withdrawal Test Item | 10 | Pass | | Test Report Leads, Model 402X Connector Electrical Isolation | 7 | Pass | | Test Report, Two-Port Header, Model 2011 Set-Screw Seal Integrity Test Item | 10 | Pass | | Test Report, Header Connection Fixation Integrity Test Item (Model 2000) | 6 | Pass | | Test Report, Two-Port Header, Model 2011 Insertion and Withdrawal Test Item | 10 | Pass | | Test Report, 6.1 Header, Model 2012 Insertion and Withdrawal Test Item | 5 | Pass | | Test Report, 6.1 Header, Model 2012 Connector Electrical Isolation Test Item | 10 | Pass | | Test Report, 6.1 Header, Model 2012 Fixation Integrity Test Item | 6 | Pass | | Test Summary Report for Model 2000 ICD: Software, Hardware, Environmental | N/A | Pass | | Test Summary Report, Functional Device Test, ICD | N/A | Pass | | Test Summary Report, System, Model 2000 ICD, Software Integration | N/A | Pass | | Defibrillator/Pacemakers, Susceptibility Report | 2 | Pass | | Qualification Test Report, Distribution Simulation Test, ICD Model 2010 | 3 | Pass | | Test Summary Report for Model 2010 Family ICD: Software, Hardware, Environmental | N/A | Pass | | Test Summary Report, Functional Device Test for Model 2010 Series ICD | N/A | Pass | | Software Integration Test Summary Model 2010 ICD | N/A | Pass | | Leads and Accessory Reports: | | | | Test Report Leads, Model 40XX Stylet, Connector and Introducer Insertion/Withdrawal Force; and Set Screw Deformation | 7 leads 8 headers | Pass | {12} Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 13 20 | Test Performed | Number of Samples | Test Result | | --- | --- | --- | | Test Report Leads, Model 40XX Terminations, Bonds, and Tines | Various samples (19, 16, 15) depending on bond location | Pass | | Test Report, AngeFlex Lead with DFT Outer Coil Flex Fatigue Test Item | 16 | Pass | | Test Report Leads, Model 402X Thermal Cycling | 10 | Pass | | Test Report Leads, Model 402X Air Pressure | 7 | Pass | | Test Report Leads, Model 402X Connector Electrical Isolation | 9 | Pass | | Test Report Leads, Model 4020 Series Clavicle First Rib | 10 | Pass | | Test Report Leads, Model 4020 Series Anchoring Sleeve | 15 | Pass | | Test Report Leads, Model 402X Burst and Peel | 6 | Pass | | Test Reports Leads, Model 40XX Shipping Test | 7 | Pass | | Test Report Leads, 6.1 to DF-1 Adapter Workmanship Test Item | 20 | Pass | | Test Report Leads, 6.1 to DF-1 Adapter Connector Introducer Insertion/Withdrawal, Set Screw Deformation Test Item | 5 | Pass | | Test Report Leads, 6.1 to DF-1 Adapter Conductor Terminations and Joint Bonds Test Item | Various samples (15, 13, 10) depending on bond location | Pass | | Test Report Leads, 6.1 to DF-1 Adapter Thermal Cycling Test Item | 32 | Pass | | Test Report Leads, 6.1 to DF-1 Adapter Lead Durability and Insulation Integrity Test Item | 6 | Pass | | Test Report Leads, 6.1 to DF-1 Adapter Connector Electrical Isolation Test Item | 6 | Pass | | Test Report Leads, 5.1 to DF-1 Adapter Set Screw Seal Integrity Test Item | 5 | Pass | | Test Report Lead, Model 40XX Flex Testing (as referenced by AngeFlex Test Report) | 16 | Pass | | Test Report Leads, 6.1 to DF-1 Adapter Package Shipping Test Item | 5 | Pass | | Test report Leads, 6.1 to DF-1 Adapter Pressure Burst and Peel Strength Test Item | 6 | Pass | | **Externals and Accessories Reports:** | | | | Test Summary Report for Model 2000 Programmer System: Software, Hardware, Environmental | Various samples, depending on the tests | Pass | | Test Summary Report for Model 2010/2011/2012 Programmer System: Software, Hardware, Environmental | Various samples, depending on the tests | Pass | | Qualification Test Report, Distribution Simulation Test, System Programmer Model 3007 | 3 | Pass | | Test Summary Report, SYP IDF Application Integration Test | 1 System | Pass | | Test Summary Report, SYP IDF Functional Test | 1 System | Pass | | Test Summary Report, Model 2000 IDF | 1 System | Pass | | Test Summary Report, SYP DTS Application Integration Test | 1 System | Pass | | Test Summary Report, SYP/DTS Functional Test | 1 System | Pass | | Test Summary Report, Model 7001 DTS | DTS, Smart Wand, Programmer Software | Pass | | Test Summary Report, SYP, ICD Model 2010-Series Application Software Integration Test | ICD/Programmer System | Pass | | Test Summary Report, SYP, Functional Device Test for Model 2010-Series ICD Application | ICD/Programmer System | Pass | | Test Summary Report, Model 2010 ICD | 2010/3003/3002 Software | Pass | | Test Summary Report for Model 2010 Phase II (400229-001 & 700033-001) plus Addendum to Test Summary Report for Model 2010 Phase II | 2010/DTS/Smart Wand/Programmer Software | Pass | | Qualification Test Report, Distribution Simulation, Test Printer Model 3008 | 3 | Pass | | Test Summary Report for the DTS 7001 | N/A | Pass | | Test Summary Report for the DTS 7002 | N/A | Pass | | Test Summary Report, DTS Functional Device | N/A | Pass | | Qualification Test Report, DTS, Model 7001 | 5 | Pass | | Qualification Test Report, Final Device, DTS, Model 7002 | 2 | Pass | | Smart Wand Main Board Assembly Qualification Report | 5 | Pass | | Smart Wand RF Board Assembly Qualification Report | 5 | Pass | | Test Summary Report for Model 3003 Smart Wand: Hardware, Software, Environmental | 1 each | Pass | | Qualification Test Report, SWD, Model 3003 | 2 | Pass | | Test Report, Test Can Electrode Summary: Thermal Cycling; Burst and Peel Strength (Packaging); Workmanship; Terminations, Bonds and Welds; DC Resistance and Conductor Integrity; Insulation Integrity | 5 | Pass | {13} | Test Performed | Number of Samples | Test Result | | --- | --- | --- | | Animal Study Reports: | | | | Pre-Clinical Investigation of the Sentinel ICD and AngeFlex Defibrillation Lead Systems, Animal Study Report | 21 canines | System performed as intended (per Angeion's requirements) in a clinical laboratory environment | | Pre-Clinical Evaluation of the Model 2010 Software Application, Auto Recognition, and Model 7002 Software Application (Phase II Software) with the Sentinel Devices, Programming System, and DTS, Animal Study Report | 1 canine | System performed as intended (per Angeion's requirements) in a clinical laboratory environment | | Biocompatibility Reports: | | | | Test Report, Sentinel Implantable Cardioverter Defibrillator, Model 2000 Biocompatibility Testing | Various samples sizes depending on each test | Pass | | Special Evaluation: Pellethane ICD Header, Autoclave vs. EtO Sterilized Material Comparison | 2 | Pass | | Test Report, Two-Port ICD Header, Model 2011 Biocompatibility Testing | 42 | Pass | | Test Report, AngeFlex Transvenous Defibrillation Leads, Model 4020 Series Biocompatibility Testing | Various sample sizes depending on each test | Pass | | Test Report, AngeFlex Lead Supplementary Biocompatibility Testing | 17 | Pass | ## 9.1 Sentinel ICD Component Bench Tests The electronic components of the Sentinel ICD were subjected to qualification of the individual component, subassembly and device level depending on the particular component. The qualification consisted of electrical, mechanical, dimensional, and visual requirements, depending on the component or subassembly. The electronic circuitry of the ICDs was subjected to qualification testing including electrical, temperature cycling, visual, and vacuum bake with visual exams. The batteries for the Sentinel ICDs were subjected to environmental stresses followed by visual exam, dimensional analysis, radiographic analysis, electrical and hermeticity testing. Additionally, the battery dissipation characteristics over the life of the battery were determined. Based on the longevity calculations, the estimated longevity of the ICD is between 5 and 9.3 years. The calculation for 5 years is based on 100% pacing and 12 shocks per year, and the calculation for 9.3 years is based on 0% pacing and 4 shocks per year. The high voltage shocking capacitors of the Sentinel ICD were qualified to meet the following requirements: external visual and mechanical, internal visual, DC current leakage, capacitance, mechanical shock and vibration, temperature cycling, charge/discharge testing, and life testing. ## 9.2 Sentinel ICD/System Bench Tests - Mechanical/environmental testing of the Sentinel ICD devices consisted of exposure to diagnostic ultrasound, vibration, drop, and temperature cycling testing. Tests were also performed to verify visual, adhesion, and electrical requirements for the associated header connectors of the ICDs. - Electrically, Sentinel ICDs were tested for performance of programmed parameters and non-programmable settings. Pulse rate, pulse width and amplitudes were also verified as part of the testing. - The Sentinel ICDs were tested for Electromagnetic Interference (EMI) in various orientations. Additionally, Sentinel ICDs were exposed to radiated electromagnetic fields at 450 MHz and 2450 MHz. The Sentinel ICD did not exhibit any changes from specification during the course of the testing. Testing for conducted radio frequency energy at the 100 mV level exhibited some interference. Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 14 {14} - The System Programmer software applications consisting of the Model 2000 ICD, Model 2010/2011/2012 ICDs, and the DTS underwent a series of tests at the device and system levels. This testing verified that the software and the devices conformed to the requirements. - The shelf life for the Sentinel ICD, leads and most accessories is 12 months. All packaging materials are commonly used industry materials that have been evaluated for their sealing integrity. - A temperature storage test was performed on the Sentinel ICD where the device was exposed to +55°C and -30 °C for up to 96 hours. Final electrical testing after each temperature exposure demonstrated that the devices were unaffected by these temperature extremes. The recommended storage temperature for the Sentinel ICD is between -10°C and +55°C. ## 9.3 Lead System and Accessory Bench Tests Testing of the AngeFlex Defibrillation Lead System included electrical and mechanical tests which included: flex fatigue, shock stability, thermal cycling, DC resistance, and connector tests. Additionally, the DTS, patient cables, and other system accessories were subject to various mechanical and electrical tests. ## 9.4 Biocompatibility Studies The tissue/body fluid contacting materials of the Sentinel ICD System and the AngeFlex Defibrillation Lead System were evaluated for biocompatibility with the following tests: irritation, sensitization, cytotoxicity, hemolysis, pyrogenicity, mutagenicity, implantation and chronic toxicity tests. All of the implantable materials and processes are common to the industry and have a long history as implantable materials. ## 9.5 Animal Studies Two animal studies were performed to evaluate the Sentinel ICD System and the AngeFlex Defibrillation Lead System. The first was a chronic study involving 21 canines that were followed over the course of two years. The study was performed to evaluate acute and chronic defibrillation thresholds, overall ICD/Lead performance, and to assess histological affects. The ICD/Lead Systems performed in accordance with the established animal study protocol. The second study consisted of an acute evaluation of the performance of ICD Models 2000/2010/2011/2012, the System Programmer Models 3002/3007 (with Model 3008 Printer) in combination with various leads and accessories. This assessed overall system compatibility and evaluation of device performance to requirements. The ICD/Lead Systems and accessories performed in accordance with the established animal study protocol. ## 10.0 Clinical Study The purpose of the clinical study was to evaluate the safety and effectiveness of the Sentinel ICD System Models 2000/2010/2011/2012 using the AngeFlex Transvenous Defibrillation Lead System Models 4020/4021/4022/4023, the AngePass Defibrillation Lead System 4040/4080 Series, the Endocure 1500 Series Defibrillation Lead System, or a chronic defibrillation lead Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 15 {15} system under IDE #G950164. The study was initiated (first implant) on March 26, 1996. All centers used a common investigational protocol. The Sentinel ICD clinical summary includes data collected as of December 1, 1997, and includes information for 148 screened patients; 138 of whom were implanted with the Sentinel ICD. The AngeFlex Defibrillation Lead System was implanted in 70 patients, the Endocure lead(s) in 56 patients, the AngePass Lead System in 4 patients, and 8 patients had previously placed market approved chronic defibrillation lead systems. Even though the Sentinel ICD performance data includes Sentinel ICD Systems implanted with the AngePass and the Endocure Defibrillation Lead Systems, Angeion is not seeking approval of the AngePass Defibrillation Lead System or Endocure Lead Systems with this PMA application. ## 10.1 Objectives The key study objectives to determine the clinical safety and effectiveness included the following: - Estimate the rate of successful conversion of VT/VF. - Estimate the probability of 6 month survival from death by all causes over time. - Estimate the probability of 6 month survival from cardiac death over time. - Describe the performance of the AngeFlex Transvenous Defibrillation Lead System. ## 10.2 Patient Population and Gender Bias Analysis ### 10.2.1 Sentinel ICD System Study Patients There were 148 patients screened and 138 patients who were implanted with the Sentinel ICD System at fourteen centers. As of the December 1, 1997 data cutoff, 103 patients were implanted for six months or more and 48 patients were implanted for twelve months or more. Table 9: Description of Sentinel ICD System Patient Population | Characteristics | Sentinel 2000 | Sentinel 2010/2012 | All | | --- | --- | --- | --- | | Mean Age at Implant Years (Range) | 64.2 (36-82) | 64.9 (38-86) | 64.7 (36-86) | | Gender: | | | | | Male | 34 (77%) | 89 (86%) | 123 (83%) | | Female | 10 (23%) | 15 (14%) | 25 (17%) | | Mean Ejection Fraction % (Range) | 32.2% (15-67%) | 31.0% (15-70%) | 31.4% (15-70%) | Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 16 {16} | NYHA (New York Heart Association) | | | | | --- | --- | --- | --- | | I | 20 (46%) | 28 (32%) | 48 (37%) | | II | 19 (43%) | 41 (48%) | 60 (46%) | | III | 5 (11%) | 17 (20%) | 22 (17%) | | IV | 0 ( 0%) | 0 ( 0%) | 0 N/A | | Cardiovascular History* | | | | | No History | 1 ( 2%) | 2 ( 2%) | 3 ( 2%) | | CAD | 38 (86%) | 75 (72%) | 113 (76%) | | MI | 26 (59%) | 67 (64%) | 93 (63%) | | CHF | 16 (36%) | 34 (33%) | 50 (34%) | | CM | 16 (46%) | 43 (41%) | 59 (40%) | | Primary Arrhythmia: | | | | | VT | 31 (70%) | 63 (61%) | 94 (64%) | | VF | 11 (25%) | 25 (24%) | 36 (24%) | | VT/VF | 2 ( 5%) | 9 ( 8%) | 11 ( 7%) | | MADIT | 0 ( 0%) | 7 ( 7%) | 7 ( 5%) | | Implant Defibrillating Lead System Configuration | | | | | RV/Can | | | | | RV/SVC/Can | 9 (21%) | 51 (53%) | 60 (43%) | | RV/SVC | 30 (72%) | 39 (41%) | 69 (50%) | | | 3 ( 7%) | 6 ( 6%) | 9 ( 7%) | | Defibrillation Threshold (DFT) (# Patients) | | | | | Implant - ICD | 9.5J ( 6) | 10.0J (12) | 9.8J (18) | | Pre-Discharge | 8.5J (19) | 10.2J (14) | 9.2J (33) | | 1 Month | 9.1J (21) | 7.9J ( 6) | 8.8J (27) | | 3 Months | 10.8J ( 7) | 9.0J (17) | 9.5J (24) | | 6 Months | 9.4J (17) | 14.3J ( 1) | 9.6J (18) | * Cardiac disease was indicated on case report form, however, primary cardiac disease was not, therefore these categories do not add up to 100%. ## 10.2.2 Gender Bias Analysis Of all patients enrolled, 17% (N = 25/148) were females. Inclusion and exclusion criteria were chosen to avoid gender bias. The preponderance of male patients reflected the gender referral pattern for cardiac disease. Analyses of safety and effectiveness relative to male and female patients indicated no difference between the genders. There were no statistically significant differences in the demographic variables between the Sentinel ICD Model 2000 and Model 2010 groups. These data are therefore considered poolable. ## 10.3 Study Design The Sentinel ICD System clinical trial was conducted as a prospective, non-randomized, multicenter study. The study was designed to evaluate the Sentinel ICD System performance as compared to objective performance criteria. As this was the first device of its kind for Angeion, there was no Angeion predicate device to use for comparison or control. The objective performance criteria were established based on a review of the literature which described the performance of several market approved ICDs. Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System {17} # 10.4 Clinical Results ## 10.4.1 Statistical Analysis The safety and effectiveness of the Sentinel ICD System were demonstrated through various statistical analyses. The statistical methods used in analyzing the stratified data were: Pearson’s $\chi$ to test for the significance of differences between variables that were categorical in nature; Kruskal-Wallis Analysis of Variance to determine the statistical significance of comparisons between groups where the dependent variable was ordinal in nature; Student’s t-test for significance of differences between variables which were continuous; paired t-test to evaluate the significance of differences between measurements of continuous variables obtained on the same patients; and, Wilcoxon’s Matched-Pairs signed-ranks test for measurements obtained on the same patient at different points in time or under different treatments. The Kaplan-Meier product limit survival method was conducted to analyze mortality endpoints at six months. ## 10.4.2 Induced and Spontaneous Arrhythmia Episode Experience One of the primary endpoints was to demonstrate conversion efficacy, i.e., the Sentinel ICD System appropriately detects and terminates induced and spontaneous ventricular tachyarrhythmias. The data presented below includes induced and spontaneous VT and VF episodes from all implants and all follow-ups. Other rhythms are those that were deemed to be detected and attempted to be treated by the Sentinel ICD System but were not tachyarrhythmias (atrial fibrillation, sinus tachycardia, etc.). The induced data were witnessed by the investigator (or associate) and also recorded via the Sentinel Event History Log and via real time chart recorder. The Sentinel ICD memory (Event History) was used to verify spontaneous events. Table 10: Arrhythmia Conversion Sentinel ICD System Population (N = 148) | Arrhythmia Classification | Induced/ Spontaneous | Number of Episodes | Number of Arrhythmias Converted by Device | | --- | --- | --- | --- | | VT | Induced | 472 | 471 (99%) | | | Spontaneous | 723 | 718 (99%) | | VF | Induced | 1215 | 1214 (99%) | | | Spontaneous | 61 | 61 (100%) | | Other | Spontaneous | 26 | 7 (27%) | ## 10.4.3 Patient Survival Survival from all causes and cardiac causes was also a primary study endpoint. A six month survival analysis was conducted after the first 100 enrolled patients reached the 6 month follow-up. These results were compared to the Objective Performance Criteria. Percentage of survival is based on Kaplan-Meier product limit analysis. Table 11: Safety Results Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 18 {18} | SAFETY MEASURES | Total Survival | | Objective Performance Criteria (OPC) (6 month survival) | | --- | --- | --- | --- | | | # alive patients/# implanted patients | % survival (Kaplan-Meier) | | | Survival: Cardiac Cause | 130/136 | 97% | 97% | | Survival - All Causes | 130/138 | 96% | 93% | ## 10.4.4 Clinical Events (Observations and Complications) For purposes of the clinical study, the reported medical events were identified as observations and complications. An observation was defined as a physician reported symptomatic or asymptomatic clinical event with potential adverse effects which does not require invasive intervention. A complication is a similar clinical event but which requires invasive intervention. (Specific details regarding these events can be found in previous Tables 6 and 7). ## 10.4.5 Device Accountability, Reliability, and Longevity Table 11 provides a summary of all Sentinel ICD Systems and associated leads used in the Sentinel ICD System clinical investigation. ### Table 12: Device Accountability Total devices implanted: Sentinel ICD System (N = 143*), AngeFlex Defibrillation Lead Systems (N = 70), Endocure lead system (N = 56), and other lead system (N = 12). | | Sentinel 2000 | Sentinel 2010/2012 | All | | --- | --- | --- | --- | | Devices Implanted: | 42 | 101 | 143* | | Still Active | 38 | 92 | 130 | | Out-of-Service | 4 | 9 | 13 | | Out-of-Service Devices: | 4 | 9 | 13 | | Due to Deaths | 2 | 6 | 8 | | Due to Explant | 2 | 3 | 5 | | Not Returned | 2 | 5 | 7 | | Analyzed | 2 | 4 | 6 | | Returned Devices | 2 | 4 | 6 | * Includes 5 replacement devices ## 11.0 Conclusions Drawn from the Studies Prior to the start of U.S. clinical studies, the Sentinel ICD System and AngeFlex Defibrillation Lead System were subjected to comprehensive bench testing at the component, subassembly, device and system levels. All materials contacting tissue and body fluids were evaluated for biocompatibility. Acute and chronic animal studies were also conducted with all of devices included in the PMA application. In addition, the safety and effectiveness of the Sentinel ICD Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System {19} Systems were also comprehensively evaluated and demonstrated through the clinical studies. Therefore, it is reasonable to conclude that the benefits of use of the device for the target population outweigh the risk of illness or injury when used as indicated in accordance with the directions for use. ## 12.0 Panel Recommendation In accordance with the provisions of section 515(c)(2) of the act as amended by the Safe Medical Devices Act of 1990, this PMA was not referred to the Circulatory System Devices Panel, an FDA advisory committee, for review and recommendation because the information in the PMA substantially duplicates information previously reviewed by this panel. ## 13.0 FDA Decision Based on the review of the original submission and its amendments, the applicant has addressed all the major issues. FDA issued an approval order on August 19, 1998. The applicant’s manufacturing facility was inspected on April 8, 1998, and was found to be in compliance with the device Good Manufacturing Practice regulations. ## 14.0 Approval Specifications Directions for use: See the labeling. Hazards to Health from Use of the Device: See Indications, Contraindications, Warnings, Precautions and Adverse Events in the labeling. Post-approval Requirements and Restrictions: See approval order. The Approval Order, Summary of Safety and Effectiveness Data, and labeling can be found on the Internet at http://www.fda.gov/cdrh/pmapage.html. Summary of Safety and Effectiveness, P970024, Sentinel ICD and AngeFlex Defibrillation Lead System Page 20