PULSE GENERATOR USER'S MANUAL EMBLEM™ S-ICD Subcutaneous Implantable Cardioverter Defibrillator MODEL A209 CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow-up procedures.
EMBLEM is a trademark of Boston Scientific. This product may be protected by one or more patents. Patent information can be obtained at http://www. bostonscientific.com/patents.
Table of Contents Description 1 Related Information 1 Intended Audience 1 Indications for Use 1 Contraindications 1 Warnings 1 General 1 Handling 2 Implantation 2 Post-Implant 3 Precautions 3 Clinical Considerations 3 Sterilization and Storage 4 Implantation 4 Device Programming 5 Environmental and Medical Therapy Hazards 6 Hospital and Medical Environments 6 Home and Occupational Environments 10 Follow-up Testing 12 Explant and Disposal 12 Supplemental Precautionary Information 12 Potential Adv
Safety and Effectiveness Results 24 Effectiveness Results 32 Subgroup Analyses 35 Conclusion 36 Patient Screening 37 Collecting the Surface ECG 37 Evaluating the Surface ECG 38 Determining an Acceptable Sense Vector 40 Operation 41 General 41 Modes of Operation 41 Shelf Mode 41 Therapy On Mode 41 Therapy Off Mode 41 Sensing Configuration and Gain Selection 42 Sensing and Tachyarrhythmia Detection 42 Detection Phase 42 Certification Phase 43 Decision Phase 43 Therapy Zones 43 Analysis in the
Arrhythmia Induction 47 System Diagnostics 47 Subcutaneous Electrode Impedance 48 Device Integrity Check 48 Battery Performance Monitoring System 48 Storing and Analyzing Data 49 Treated Episodes 49 Untreated Episodes 49 Captured S-ECG 49 S-ECG Rhythm Strip Markers 50 Patient Data 51 S-ICD System Magnet Use 52 Magnet use for patients with deep implant placement 53 Magnet Response and Pulse Generator Mode 54 Bidirectional Torque Wrench 55 Using the EMBLEM S-ICD Pulse Generator 55 Items Includ
Communication Compliance 72 Federal Communications Commission (FCC) Compliance 72 Additional Information 72 Product Reliability 72 Pulse Generator Longevity 73 Specifications 74 X-ray Identifier 74 Definitions of Package Label Symbols 81 S-ICD System and Pacemaker Interaction 83 Warranty Information 84
Description The EMBLEM™ S-ICD pulse generator (the “device”) is a component of the Boston Scientific S-ICD System, which is prescribed for patients when cardiac arrhythmia management is warranted. The pulse generator accepts one EMBLEM S-ICD subcutaneous electrode with an SQ-1 S-ICD connector.1 The EMBLEM S-ICD pulse generator is also compatible with the Cameron Health Model 3010 Q-TRAK subcutaneous electrode.
• For single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or • • • Handling resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death.
Post-Implant • Magnet Response. Use caution when placing a magnet over the S-ICD pulse generator because it • • • • • suspends arrhythmia detection and therapy response. Removing the magnet resumes arrhythmia detection and therapy response. Magnet response with deep implant placement. In patients with a deep implant placement (greater distance between the magnet and the pulse generator) magnet application may fail to elicit the magnet response. In this case the magnet cannot be used to inhibit therapy.
Sterilization and Storage • If package is damaged. The blister trays and contents are sterilized with ethylene oxide gas before • • • • final packaging. When the pulse generator and/or subcutaneous electrode is received, it is sterile provided the container is intact. If the packaging is wet, punctured, opened, or otherwise damaged, return the pulse generator and/or subcutaneous electrode to Boston Scientific. If device is dropped.
• Do not bend the subcutaneous electrode near the electrode-header interface. Insert the • subcutaneous electrode connector straight into the pulse generator header port. Do not bend the subcutaneous electrode near the subcutaneous electrode-header interface. Improper insertion can cause insulation or connector damage. Subcutaneous Electrode connections.
• Programming for supraventricular tachyarrhythmias (SVTs). Determine if the device and programmed parameters are appropriate for patients with SVTs because SVTs can initiate unwanted device therapy. Environmental and Medical Therapy Hazards • Avoid electromagnetic interference (EMI). Advise patients to avoid sources of EMI because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.
• Cardiopulmonary resuscitation. Cardiopulmonary resuscitation (CPR) may temporarily interfere with sensing and may cause delay of therapy. • Electrical interference. Electrical interference or “noise” from devices such as electrocautery and • monitoring equipment may interfere with establishing or maintaining telemetry for interrogating or programming the device.
• Electrocautery and Radio Frequency (RF) Ablation. Electrocautery and RF ablation may induce ventricular arrhythmias and/or fibrillation, and may cause inappropriate shocks and inhibition of post-shock pacing. Additionally, exercise caution when performing any other type of cardiac ablation procedure in patients with implanted devices. If electrocautery or RF ablation is medically necessary, observe the following to minimize risk to the patient and device: Program the pulse generator to Therapy Off mode.
• Off mode prior to the treatment, and monitor device performance during the treatment. After the treatment, verify pulse generator function ("Post-Therapy Pulse Generator Follow-Up" on page 12). Transcutaneous Electrical Nerve Stimulation (TENS). TENS involves passing electrical current through the body, and may interfere with pulse generator function. If TENS is medically necessary, evaluate the TENS therapy settings for compatibility with the pulse generator.
Home and Occupational Environments • Home appliances. Home appliances that are in good working order and properly grounded do not • • • usually produce enough EMI to interfere with pulse generator operation. There have been reports of pulse generator disturbances caused by electric hand tools or electric razors used directly over the pulse generator implant site. Electronic Article Surveillance (EAS) and Security Systems.
Pressure for each test cycle began at ambient/room pressure, increased to a high pressure level, and then returned to ambient pressure. Although dwell time (the amount of time under elevated pressure) may have an impact on human physiology, testing indicated it did not impact pulse generator performance. Pressure value equivalencies are provided below (Table 1 on page 11). Table 1: Pressure Value Equivalencies Pressure value equivalencies Atmospheres Absolute 3.
Follow-up Testing • Low shock impedance. A reported shock impedance value of less than 25 ohms from a delivered • • shock could indicate a problem with the device. The delivered shock may have been compromised, and/ or any future therapy from the device may be compromised. If a reported impedance value of less than 25 ohms is observed, correct functioning of the device should be verified. Conversion testing.
›› Reviewing stored events, fault codes, and real-time S-ECGs prior to saving all patient data ›› Testing the subcutaneous electrode impedance ›› Verifying battery status ›› Printing any desired reports ›› Verifying the appropriate final programming prior to allowing the patient to leave the clinic ›› Ending session Potential Adverse Events Potential adverse events related to implantation of the S-ICD System may include, but are not limited to, the following: • Acceleration/induction of atrial or ventricul
• Inappropriate post shock pacing • Inappropriate shock delivery • Infection • Keloid formation • Migration or dislodgement • Muscle/nerve stimulation • Nerve damage • Pneumothorax • Post-shock/post-pace discomfort • Premature battery depletion • Random component failures • Stroke • Subcutaneous emphysema • Surgical revision or replacement of the system • Syncope • Tissue redness, irritation, numbness or necrosis If any adverse events occur, invasive corrective action and/or S-ICD System modification or rem
Clinical Summary The following clinical summary is applicable to the EMBLEM S-ICD System. The study was conducted using the first generation version of the S-ICD System. The EMBLEM System provides the same therapies for the same indications as the system used in the study.
Additional Objectives Additional objectives of the study were: • To observe the continued chronic performance of the S-ICD System during appropriate device-detected episodes of VT or VF. • To observe the continued chronic performance of the S-ICD System during induced episodes of VT or VF at least 150 days post-implant.
Accountability of PMA Cohort Of 330 patients enrolled in PMA study, 321 underwent an implant procedure, of whom 314 were implanted with the S-ICD System. There were 293 patients still active at the time of database lock on February 14, 2012. The mean follow-up duration for all patients implanted was 330 days with a range of 17 to 715 days. Cumulative time of follow-up for all implanted patients was 3,410 months.
The primary safety endpoint analysis cohort includes all patients who underwent an implant attempt for the S-ICD System (N=321). The primary effectiveness endpoint cohort includes all patients undergoing an implant attempt with complete acute induced VF conversion tests (N=304). A total of 17 patients did not complete acute induced VF conversion testing as defined in the protocol. Seven of the 17 patients were ultimately not implanted due to difficulty converting VF at 65J.
Demographic Race (n, %) Statistic/Category N=321 White or Caucasian 208 (64.8) Black or African American 76 (23.7) Hispanic or Latino 23 (7.2) Asian 6 (1.9) Asian Indian 3 (0.9) Maori 3 (0.9) Pacific Islander 2 (0.6) Height (cm) Mean ± SD (Median) Range 174.3 ± 10.2 (175.0 ) 142.2-200.7 Weight (kg) Mean ± SD (Median) Range 90.5 ± 25.2 (86.6 ) 42.6-230.9 BMI Mean ± SD (Median) Range 29.7 ± 7.2 (29.0 ) 15.2-69.
Table 3: Baseline Characteristics Attribute Creatinine (mg/dL) Ejection Fraction (%) (n=299) N=321 Mean ± SD (Median) Range 1.1 ± 0.4 (1.0 ) 0.3-3.7 Mean ± SD (Median) Range 36.1 ± 15.9 (31.0 ) 10.0-82.0 I: No Physical Limitations 68 (21.2) II: Slight Physical Limitations 146 (45.5) at Enrollment III: Marked Physical Limitations 55 (17.1) (n, %) IV: Total Physical Limitations NYHA Classification Co-morbidities History (n, %) 20 Statistic/Category 1 (0.3) Unknown/Not Assessed 51 (15.
Attribute Co-morbidities Statistic/Category N=321 Hypertension 187 (58.3) Myocardial Infarction 133 (41.4) History Stroke 18 (5.6) Valve Disease 42 (13.1) Ablation 16 (5.0) CABG 48 (15.0) Cardiac Surgical History Defibrillator 43 (13.4) (n, %) Pacemaker 4 (1.2) (n, %) Percutaneous Revascularization 92 (28.7) Valve Surgery 18 (5.
Table 4: Indications According to ACC/AHA/HRS Guidelines N=321 Indication Details Patients n (%) 22 Left ventricular ejection fraction (LVEF) less than 35% due to prior MI who are at least 40 days post-MI and are in NYHA functional Class II or III 88 (27.4) Non-ischemic DCM and an LVEF less than or equal to 35% and is in NYHA functional Class II or III 76 (23.
N=321 Indication Details Patients n (%) Familial cardiomyopathy associated with SCD 6 (1.9) Cardiac sarcoidosis or Chagas disease 4 (1.2) Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C) with risk for SCD 3 (0.9) Nonsustained VT due to prior MI, LVEF less than 40%, and inducible VF or sustained VT at electrophysiological study 2 (0.6) LV noncompaction 1 (0.3) Catecholaminergic polymorphic VT 1 (0.3) Sustained VT and normal or near-normal ventricular function 1 (0.
Safety and Effectiveness Results Safety Results The 180-day Type I complication-free rate was assessed in all patients with an attempted S-ICD System implant (N=321) for the primary safety endpoint. A Type I complication was defined as any clinical event caused by the S-ICD System that required invasive intervention. The Type I complication-free rate at 180 days was 99.0% with a lower 95% confidence bound of 97.9%.
Table 5: Kaplan-Meier Estimates for Primary Safety Endpoint Start of Interval (Days from Implant) Statistic 0 30 90 180 360 319 311 308 274 119 Cumulative Patients Censored 2 8 10 44 194 Cumulative Patients with Events 0 2 3 3 8 KM Estimate of Patients Free from Event (%) 100 99.4 99.0 99.0 96.6 95% Lower Confidence Bound 100 98.5 98.0 97.9 93.5 Number Remaining at Risk Clinical Events A Clinical Event is defined as any untoward medical occurrence in a patient.
Table 6: Clinical Event Summary by Type and Observation/Complication All patients with an implant attempt (N=321) Clinical Event Complications Events Patients (%) Observations Events Patients (%) Total Events Patients (%) Type I 12a 11 (3.4) 35 30 (9.3) 47 3 (12.1) Type II 4 4 (1.2) 0 0 (0.0) 4 4 (1.2) Type III 25 24 (7.5) 83 71 (22.1) 108 88 (27.4) Type IV 16 15 (4.7) 36 33 (10.3) 52 44 (13.7) All Clinical Events 57 48 (15.0) 154 116 (36.1) 211 139 (43.
Table 7: Type I Clinical Events All patients with an implant attempt (N=321) Clinical Event Complications Observations Total Events Patients (%) Events Patients (%) Events Patients (%) Discomfort 3 3 (0.9) 8 7 (2.2) 11 11 (3.4) Inability to Communicate with the Device 2 2 (0.6) 0 0 (0.0) 2 2 (0.6) Inappropriate Shock: Oversensing 5 5 (1.6) 25 21 (6.5) 30 25 (7.8) Numbness at Device Site 0 0 (0.0) 1 1 (0.3) 1 1 (0.3) Premature Battery Depletion 2 2 (0.6) 0 0 (0.
Table 8: Type II Clinical Events All patients with an implant attempt (N=321) Clinical Event 28 Complications Observations Total Events Patients (%) Events Patients (%) Events Patients (%) Electrode Movement 2 2 (0.6) 0 0 (0.0) 2 2 (0.6) Inappropriate Electrode Connection to the Device 1 1 (0.3) 0 0 (0.0) 1 1 (0.3) Sub-optimal Electrode Position 1 1 (0.3) 0 0 (0.0) 1 1 (0.3) All Type II Clinical Events 4 4 (1.2) 0 0 (0.0) 4 4 (1.
Table 9: Type III Clinical Events All patients with an implant attempt (N=321) Clinical Event Complications Observations Total Events Patients (%) Events Patients (%) Events Patients (%) Acute Hypoxic Respiratory Failure 0 0 (0.0) 1 1 (0.3) 1 1 (0.3) Adverse Reaction to Medication 3 3 (0.9) 5 5 (1.6) 8 8 (2.5) Atrial Fibrillation / Flutter 0 0 (0.0) 14 14 (4.4) 14 14 (4.4) Bleeding 0 0 (0.0) 1 1 (0.3) 1 1 (0.3) Discomfort 1 1 (0.3) 12 12 (3.7) 13 12 (3.
Clinical Event Observations Total Events Patients (%) Events Patients (%) Events Patients (%) 4 4 (1.2) 17 14 (4.4) 21 16 (5.0) Incision/ Superficial Infection 1 1 (0.3) 13 13 (4.0) 14 14 (4.4) Keloid 1 1 (0.3) 0 0 (0.0) 1 1 (0.3) Local Tissue Reaction 0 0 (0.0) 1 1 (0.3) 1 1 (0.3) Numbness at Device Site 0 0 (0.0) 1 1 (0.3) 1 1 (0.3) PG Movement/ Revision 1 1 (0.3) 0 0 (0.0) 1 1 (0.3) Phantom Shock 0 0 (0.0) 5 3 (0.9) 5 3 (0.
Clinical Event Complications Observations Total Events Patients (%) Events Patients (%) Events Patients (%) Sub-optimal PG and Electrode Position 3 3 (0.9) 0 0 (0.0) 3 3 (0.9) Sub-optimal Pulse Generator Position 1 1 (0.3) 0 0 (0.0) 1 1 (0.3) Suspected Worsening of Ischemia 1 1 (0.3) 0 0 (0.0) 1 1 (0.3) System Infection 4 4 (1.2) 0 0 (0.0) 4 4 (1.2) 25 24 (7.5) 83 71 (22.1) 108 88 (27.
Device Explants Eleven (11) patients exited the study after the S-ICD System was removed for: system infection (4), oversensing (2), premature battery depletion (1), transvenous device implanted to provide overdrive pacing for ventricular arrhythmia trigger suppression (1), elective explant due to the development of an indication for biventricular pacing (1), elective explant due to development of high defibrillation threshold (1), and elective due to patient request (1).
Table 10: Effectiveness Endpoint Result - Acute VF Conversion Rate Patients undergoing acute VF conversion testing (N=320) Evaluable Results Nonevaluable Results Successful Failure 16 304 0 Estimate (%) 95% ClopperPearson Interval (%) 100.0 (98.8-100.0) Of the 16 non-evaluable patients, 11 were associated with at least one failed conversion attempt at 65 J and, due to physician discretion, did not exhaust all of the protocol defined induction attempts in both shock polarities.
Table 11: Conversion Effectiveness of Discrete Device Episodes (non-Storm) Patients with discrete episodes (N=21); Discrete device episodes (N=38) Rhythm Patients Device Episodes Episode Converted by 1st Shock (%) Episode Converted by Any Shock(%) MVT 13 22 21 (95.5) 21 (95.5) PVT/VF 11 16 14 (87.5) 16 (100.0) Total 21 38 35 (92.1) 37 (97.
The rate of successful conversion by a sub-maximal (65J) S-ICD System shock was 72/75 (96.0%). All 3/75 (4.0%) patients who failed to convert with a sub-maximal (65J) S-ICD System shock in either polarity were successfully converted with a subsequent higher-energy S-ICD System shock. Subgroup Analyses Stepwise logistic regression models (backward elimination with a threshold p-value of 0.
Conclusion The purpose of the S-ICD System Clinical Investigation was to evaluate the safety, effectiveness and chronic performance of the S-ICD System. There were 330 patients enrolled in the study and 321 underwent an implant procedure. The 314 patients implanted with the S-ICD System generated 3,410 months of patient data. The data demonstrate that the S-ICD System operates appropriately per design for the S-ICD System’s intended uses and as described in the S-ICD System’s labeling.
Patient Screening The patient screening tool, Model 4744 (Figure 3) is a customized measurement tool made of transparent plastic printed with colored profiles. The profiles are designed to ensure appropriate device performance by identifying signal characteristics that may lead to unsatisfactory detection outcomes for a patient before implant.
• ECG Electrode RA should be placed 14 cm superior to the ECG Electrode LA, to represent the intended position of the distal sensing tip of the implanted subcutaneous electrode. A 14 cm guide is located at the bottom of the transparent screening tool. SIMULTANEOUS 3-LEAD ECG 1. RECORD Supine + Standing 25 mm/s, 5-20 mm/mV Figure 4: Typical placement of surface ECG electrodes for patient screening 2.
Each QRS complex is evaluated as follows: 1. Select the colored profile from the Patient Screening Tool that best matches the amplitude of the QRS (Figure 5). For biphasic signals, the larger peak should be used to determine the appropriate colored profile. The QRS peak must fall within the window bounded by the dotted line and the peak of the colored profile. Note: ECG gains > 20 mm/mV are not permitted.
3. Evaluate the QRS complex. If the entire QRS complex and trailing T-wave are contained within the colored profile, the QRS is deemed acceptable. If any portion of the QRS complex or trailing T-wave extends outside of the colored profile, the QRS is deemed unacceptable (Figure 6). 3. VERIFY at least one lead is acceptable in all postures. Figure 6: Evaluating the QRS complex 4. Repeat the above steps with all QRS complexes collected with all surface ECG leads in all collected postures.
Note: Special circumstances may present in which the physician elects to proceed with the implantation of the S-ICD System despite failing the screening process. In this case, careful attention should be applied to the device setup process of the S-ICD System as the risk of poor sensing and/or inappropriate shock is increased. Operation General The S-ICD System is designed for ease of use and simplicity of patient management.
The device automatically defaults to Therapy Off when taken out of Shelf mode. Note: Manual and rescue shock therapy are available when the device is set to Therapy On or Therapy Off mode, but only after the initial Setup process is complete. Refer to Setting up the EMBLEM S-ICD Pulse Generator on page 65.
Certification Phase The Certification Phase examines the detections and classifies them as certified cardiac events or as suspect events. Certified events are used to ensure that an accurate heart rate is passed to the Decision Phase. A suspect event can be one whose pattern and/or timing indicates the signal is caused by noise, such as a muscle artifact or some other extraneous signal. Events are also marked as suspect if they appear to derive from double or triple detections of single cardiac events.
The device declares a Tachycardia when the 4RR average enters either therapy zone. Once a Tachycardia is declared, the 4RR average must become longer (in ms) than the lowest rate zone plus 40 ms for 24 cycles for the device to consider the episode to have ended. In the Shock Zone, treatable arrhythmias are determined by rate alone. Analysis in the Conditional Shock Zone In contrast, rate and morphology are analyzed in the Conditional Shock Zone.
Charge Confirmation The device must charge the internal capacitors before shock delivery. Confirmation of the ongoing presence of a tachyarrhythmia requires monitoring a moving window of the 24 most recent intervals defined by certified events. Charge confirmation employs an X (treatable interval) out of Y (total intervals in the window) strategy to accomplish this. If 18 of the 24 most recent intervals are found to be treatable, the device begins to analyze rhythm persistence.
Redetection A blanking period is enabled following delivery of a high-voltage shock. After delivery of the first shock, up to four additional shocks will be delivered if the episode does not terminate. Rhythm analysis for delivering shocks 2 - 5 generally follows the detection steps described above, with the following exceptions: 1. Following the first shock delivery, the X/Y criterion is modified to require 14 treatable intervals in the last 24 (14/24), rather than 18. 2.
Auto Capacitor Reformation The device automatically performs a full-energy (80 J) capacitor reformation when taken out of Shelf mode and every four months until the device reaches Elective Replacement (ERI). The energy output and reformation time interval are nonprogrammable. The Auto Capacitor Reformation interval is reset after any 80 J capacitor charge is delivered or aborted.
Subcutaneous Electrode Impedance A subcutaneous electrode integrity test is performed once a week using a sub-threshold energy pulse. The Summary report indicates whether the measured impedance is in range by reporting "Ok" for values below 400 ohms. Values above 400 ohms will result in activation of the internal warning system (beeping tones).
Storing and Analyzing Data The device stores S-ECGs for up to 25 treated and 20 untreated tachyarrhythmia episodes. An episode is only stored if it progresses to the point where charging is initiated. The number of treated episodes, untreated episodes, and the therapy shocks delivered since the last follow-up procedure and initial implant are recorded and stored. Through wireless communication with the programmer, the stored data is retrieved for analysis and report printouts.
S-ECG Rhythm Strip Markers The system provides S-ECG annotations (Table 13) to identify specific events during a recorded episode. Sample annotations are shown for the programmer display (Figure 9) and the printed report (Figure 10).
Figure 9: Programmer display markers S S S S S S S Figure 10: Printed Report Markers Patient Data The device can store the following patient data, which can be retrieved and updated through the programmer: • Patient’s name • Physician’s name and contact information • Device and subcutaneous electrode identification information (model and serial numbers) and implant date • Patient Notes (displayed upon connection to the device) 51
S-ICD System Magnet Use The Boston Scientific magnet Model 6860 (the magnet) is a non-sterile accessory that may be used to temporarily inhibit the delivery of therapy from the device if necessary. The Cameron Health magnet Model 4520 may be used interchangeably with the Boston Scientific magnet for this purpose. Note: When long duration therapy suspension is desired, it is recommended to modify pulse generator behavior with the programmer rather than the magnet whenever possible.
Figure 12: Grey shading indicates the zone within which magnet placement is most likely to suspend therapy, as signaled by beeping tones. Sweep the magnet vertically and horizontally across the target zone as indicated by the arrows.
Warning: In patients with a deep implant placement (greater distance between the magnet and the pulse generator) magnet application may fail to elicit the magnet response. In this case the magnet cannot be used to inhibit therapy. Magnet Response and Pulse Generator Mode The effect of the magnet on the pulse generator varies depending on the Mode the pulse generator is programmed to (Shelf, Therapy On, or Therapy Off) as shown in Table 14.
Bidirectional Torque Wrench A torque wrench (model 6628) is included in the sterile tray with the pulse generator, and is designed for tightening and loosening #2-56 setscrews, captured setscrews, and setscrews on this and other Boston Scientific pulse generators and lead accessories that have setscrews that spin freely when fully retracted (these setscrews typically have white seal plugs).
Implanting the S-ICD System This section presents the information necessary for implanting and testing the S-ICD System, including: • Implanting the EMBLEM S-ICD pulse generator (the “device”) • Implanting the EMBLEM S-ICD subcutaneous electrode (the “electrode”) using the EMBLEM S-ICD subcutaneous electrode insertion tool (the “EIT”) • Setting up and testing the device using the EMBLEM S-ICD programmer (the “programmer”).
Interrogate and Check the Pulse Generator To maintain sterility, test the pulse generator as described below before opening the sterile blister tray. The pulse generator should be at room temperature to ensure accurately measured parameters. 1. Place the wand directly over the pulse generator. 2. From the programmer startup screen, select the Scan for Devices button. 3.
Implanting the EMBLEM S-ICD Subcutaneous Electrode The procedure described below is one of several surgical approaches that can be used to appropriately implant and position the electrode. Regardless of the surgical approach, the defibrillation coil must be positioned parallel to the sternum, in close proximity to, or in contact with the deep fascia, approximately 2 cm from the sternal midline (Figure 13).
4. With the subcutaneous electrode attached, carefully pull the EIT back through the tunnel to the xiphoid incision until the proximal sensing electrode emerges. 5. Place a suture sleeve over the subcutaneous electrode shaft 1 cm below the proximal sensing electrode. Using the preformed grooves, bind the suture sleeve to the subcutaneous electrode shaft using 2-0 silk or similar non-absorbable suture material, making sure not to cover the proximal sensing electrode.
9. Using the secured suture at the superior incision, carefully pull the suture and subcutaneous electrode through the tunnel until the anchoring hole emerges. The subcutaneous electrode should be parallel to the sternal midline with the defibrillation coil in close proximity to the deep fascia. 10. Cut and discard the suture material. 11. At the xiphoid incision, secure the suture sleeve with the subcutaneous electrode to the fascia using 2-0 silk or similar non-absorbable suture material.
15. To ensure good tissue contact with the implanted subcutaneous electrode, flush the xiphoid and superior incisions with sterile saline solution and apply firm pressure along the electrode to express any residual air out through the incisions prior to closing. Connecting the Subcutaneous Electrode to the Device When connecting the subcutaneous electrode to the device, use only the tools provided in the device tray. Failure to use the supplied tools may result in damage to the setscrew.
Figure 18: Inserting the torque wrench 3. 62 With the torque wrench in place, fully insert the subcutaneous electrode terminal into the electrode port. Grip the subcutaneous electrode close to the connector and insert it straight into the connector port. The electrode is fully inserted when the tip of the connector is visible beyond the connector block when viewed from the top.
TOP VIEW No electrode inserted Setscrew Electrode fully inserted Tip of connector Setscrew Electrode Figure 19: Position of the subcutaneous electrode connector Warning: Use caution handling the subcutaneous electrode connector. Do not directly contact the connector with any surgical instruments such as forceps, hemostats, or clamps. This could damage the connector.
4. Apply gentle downward pressure on the torque wrench until the blade is fully engaged within the setscrew cavity, taking care to avoid damage to the seal plug. Tighten the setscrew by slowly turning the torque wrench clockwise, until it ratchets once. The torque wrench is preset to apply the proper amount of force to the captive setscrew; additional rotation and force is unnecessary. 5. Remove the torque wrench. 6. Apply gentle traction to the subcutaneous electrode to ensure a secure connection. 7.
12. After performing Automatic Setup, and with the device mode still set to Therapy Off, palpate the subcutaneous electrode while monitoring the real-time S-ECG on the programmer screen for evidence of inappropriate sensing. If inappropriate sensing is observed, do not proceed until it is resolved. Contact Boston Scientific for assistance if necessary. Once the baseline is stable and appropriate sensing is observed, set the device mode to Therapy On and conduct defibrillation testing if desired.
To initiate the Automatic Setup process: 1. After using the programmer to scan for devices, choose the device being implanted from the Device List screen. 2. The programmer will connect to the chosen pulse generator and the Device Identification screen will appear. Choosing the Continue button from this screen removes the pulse generator from Shelf Mode and causes the Automatic Setup screen to appear. 3. Select the Automatic Setup button to initiate Automatic Setup. 4.
5. Select the Exit button to exit the induction process and return to the Main Menu screen. The following functions occur during the test: • The S-ICD System induces ventricular fibrillation using 200 mA alternating current (AC) at 50 Hz. Induction continues until the Hold To Induce button is released (up to a maximum of 10 seconds per attempt). Note: If necessary, the induction can be terminated by disconnecting the wand from the programmer.
Patient Counseling Information The following topics should be discussed with the patient prior to discharge. • External defibrillation—the patient should contact their physician to have their pulse generator system evaluated if they receive external defibrillation • Beeping tones—the patient should contact their physician immediately if they hear tones coming from their pulse generator • Signs and symptoms of infection • Symptoms that should be reported (e.g.
Post Implant Follow-Up Procedures It is recommended that device functions be evaluated with periodic follow-up testing by trained personnel to enable review of device performance and associated patient health status throughout the life of the device. Warning: Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow-up testing. If not terminated in a timely fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.
Explantation Note: Return all explanted pulse generators and subcutaneous electrodes to Boston Scientific. Examination of explanted pulse generators and subcutaneous electrodes can provide information for continued improvement in system reliability and warranty considerations. Warning: Do not reuse, reprocess, or resterilize.
• Use a Boston Scientific Returned Product Kit to properly package the pulse generator and/or subcutaneous electrode, and send it to Boston Scientific. Loosening Stuck Setscrews Follow these steps to loosen stuck setscrews: 1. From a perpendicular position, tilt the torque wrench to the side 20º to 30º from the vertical center axis of the setscrew (Figure 22). 2.
Communication Compliance Federal Communications Commission (FCC) Compliance This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150 – 406.000 MHz band in the Meteorological Aids (i.e.
Sometimes device malfunctions result in the issuance of product advisories. Boston Scientific determines the need to issue product advisories based on the estimated malfunction rate and the clinical implication of the malfunction. When Boston Scientific communicates product advisory information, the decision whether to replace a device should take into account the risks of the malfunction, the risks of the replacement procedure, and the performance to date of the replacement device.
• One hour of additional telemetry reduces longevity by approximately 14 days • Five patient-initiated LATITUDE Communicator interrogations per week for a year reduces longevity by approximately 11 days • An additional 6 months in Shelf mode prior to implant will reduce longevity by 103 days Device longevity may also be affected by tolerances of electronic components, variations in programmed parameters, and variations in usage as a result of patient condition.
Table 16: Mechanical Specifications Dimensions Model WxHxD (mm) Mass (g) Volume (cm3) Connector Typea A209 83.1 x 69.1 x 12.7 130 59.5 SQ-1 S-ICD connector (nonstandard) a The EMBLEM S-ICD pulse generator is compatible with both the Cameron Health Model 3010 subcutaneous electrode and the EMBLEM S-ICD subcutaneous electrode. The pulse generator has a case electrode surface area of 111.0 cm2.
Table 17: Programmable Parameters Programmable Values Shock Zone 170 bpm – 250 bpm (steps of 10 bpm) 220 bpm Off, 170 bpm – 240 bpm (If On, at least 10 bpm less than Shock Zone) 200 bpm Shelf, Therapy On, Therapy Off Shelf On, Off Off Conditional Shock Zone S-ICD Pulse Generator Mode Post-shock Pacing Sensing Configuration Primary: Proximal electrode ring to device Secondary: Distal electrode ring to device Alternate: Distal electrode ring to proximal electrode ring x1 (± 4 mV) Max Sensing
Table 18: Non-Programmable Parameters (Shock Therapy) Parameter Value SHOCK THERAPY Delivered Energy Peak Shock Voltage (80 J) Shock Tilt (%) 80 J 1328 V 50% Waveform Type Biphasic Maximum Number of Shocks per episode 5 shocks Charge Time to 80 J (BOL/ERI)a Sync Time Out ≤10 sec / ≤15 secb 1 sec Shock Sync Delay 100 ms Post-Shock Blanking Period 1600 ms a Charge time is one portion of the overall time-to-therapy. BOL refers to beginning of life. b Under typical conditions.
Table 19: Non-Programmable Parameters (Post-Shock Pacing) Parameter Value POST-SHOCK PACING Rate 50 ppm Pacing Output 200 mA Pulse Width (each phase) 7.
Table 20: Non-Programmable Parameters (Detection/Rhythm Discrimination, Fibrillation Induction, Sensing, Capacitor Reform Schedule, Internal Warning System) Parameter Value DETECTION/RHYTHM DISCRIMINATION X/Y for Initial Detection 18/24 intervals X/Y for Redetection 14/24 intervals Confirmation Before Shock 3 – 24 consecutive tachy intervals Refractory Period Fast 160 ms, Slow 200 ms FIBRILLATION INDUCTION Frequency 50 Hz Output 200 mA Time out After Activation 10 sec SENSING Minimum Sensing
Table 21: Episode Data Parameters Parameter Value Treated Episodes 25 stored Untreated Episodes 20 stored Maximum Length per S-ECG Episode 128 sec Captured S-ECG Report Up to 15 (12 sec each) Table 22: Stored Patient Information Patient Information (Stored Data) Patient Name Physician Name Physician Contact Information Device Model Number Device Serial Number Electrode Model Number Electrode Serial Number Patient Notes 80
Table 23: Magnet Specifications (Model 6860) Component Specification Shape Circular Size Approximate Diameter: 2.8 in (7.2 cm) Thickness: 0.5 in (1.3 cm) Content Ferrous alloys coated with epoxy Field Strength 90 gauss minimum when measured at a distance of 1.5 in (3.8 cm) from magnet surface Note: Specifications are also applicable to the Cameron Health magnet Model 4520.
Symbol Description Description Do not reuse Manufacturer Do not resterilize Do not use if package is damaged Literature enclosed Package contents Uncoated device Lot number Pulse generator Torque wrench 82 Symbol SQ-1 SQ-1 S-ICD connector (non-standard) Reference number
S-ICD System and Pacemaker Interaction Warning: Using multiple pulse generators could cause pulse generator interaction, resulting in patient injury or a lack of therapy delivery. Test each system individually and in combination to help prevent undesirable interactions. Interaction between the S-ICD System and a temporary or permanent pacemaker is possible and can interfere with the identification of tachyarrhythmias in several ways.
4. If inappropriate sensing is observed as a result of the device sensing the pacing artifact, reduce the pacemaker’s pacing output and retest. In addition, pacemaker operation may be affected by the S-ICD System therapy delivery. This could alter the pacemaker’s programmed settings or damage the pacemaker. In this situation, most pacemakers will conduct a memory check to determine if the parameters for safe operation were affected.
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