MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0181

Device Problems High impedance (1291); Pocket Stimulation (1463); Defibrillation/Stimulation Problem (1573)

Patient Problems Cardiac Arrest (1762); Undesired Nerve Stimulation (1980)

Event Date 11/08/2022

Event Type  Injury  

Event Description

It was reported that the patient had a bike test done where a magnet was applied to the implantable cardioverter defibrillator (icd).The following day a stress test was performed and the patient went into a spontaneous ventricular tachycardia (vt) where the icd appropriately detected and delivered a shock.However the shock was ineffective, and no further therapy was delivered to the patient.The patient was rescued by the clinician by resuscitation maneuvers.The patient recovered and was hospitalized.The same day several attempts to interrogate the icd were unsuccessful despite the use of four different programmers.It was further noted that the icd would not emit beeping tones upon magnet application.Review of the data stored in the device, found it had been working appropriately prior to the stress test.There were no notable faults stored in the device's memory.Ts discussed that the icd and right ventricular (rv) lead should be explanted as there could be a possibility the device shocked into a shorted condition.The patient would be considered unprotected until explant.A few days later a revision procedure was performed.An x-ray was taken just before starting the procedure and did not show any abnormalities of the device or lead.During the procedure pacing with 5 volts using the chronic rv lead issued pocket stimulation.Pin connectors of the lead were visually fine.The yoke of the lead was completed surrounded with pocket tissue, making it impossible to observe the full lead.The rv lead pacing impedance was at 380 ohms and the shock impedance in unipolar was high at 135 ohms.The icd was able to be explanted, however the rv lead remains implanted and surgically abandoned.A new icd and rv lead were successfully implanted, and no additional adverse patient effects were reported.

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.This report is being filed to update the patient code to a more appropriate code than initially reported.

Event Description

It was reported that the patient had a bike test done where a magnet was applied to the implantable cardioverter defibrillator (icd).The following day a stress test was performed and the patient went into a spontaneous ventricular tachycardia (vt) where the icd appropriately detected and delivered a shock.However the shock was ineffective, and no further therapy was delivered to the patient.The patient was rescued by the clinician by resuscitation maneuvers.The patient recovered and was hospitalized.The same day several attempts to interrogate the icd were unsuccessful despite the use of four different programmers.It was further noted that the icd would not emit beeping tones upon magnet application.Review of the data stored in the device, found it had been working appropriately prior to the stress test.There were no notable faults stored in the device's memory.Ts discussed that the icd and right ventricular (rv) lead should be explanted as there could be a possibility the device shocked into a shorted condition.The patient would be considered unprotected until explant.A few days later a revision procedure was performed.An x-ray was taken just before starting the procedure and did not show any abnormalities of the device or lead.During the procedure pacing with 5 volts using the chronic rv lead issued pocket stimulation.Pin connectors of the lead were visually fine.The yoke of the lead was completed surrounded with pocket tissue, making it impossible to observe the full lead.The rv lead pacing impedance was at 380 ohms and the shock impedance in unipolar was high at 135 ohms.The icd was able to be explanted, however the rv lead remains implanted and surgically abandoned.A new icd and rv lead were successfully implanted, and no additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15867329
• MDR Text Key: 304327949
• Report Number: 2124215-2022-49228
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526531156
• UDI-Public: 00802526531156
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: P910073/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/04/2015
• Device Model Number: 0181
• Device Catalogue Number: 0181
• Device Lot Number: 322465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization