MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	0282
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that following a routine device changeout, this right ventricular (rv) lead exhibited non-capture.The newly implanted cardiac resynchronization therapy defibrillator (crt-d) was programmed to left ventricular (lv) only pacing and anti-tachycardia pacing (atp) was programmed off.This rv lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that following a routine device changeout, this right ventricular (rv) lead exhibited non-capture.The newly implanted cardiac resynchronization therapy defibrillator (crt-d) was programmed to left ventricular (lv) only pacing and anti-tachycardia pacing (atp) was programmed off.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that this right ventricular (rv) defibrillation lead had exhibited loss of capture (loc) since 2021 and anti-tachycardia pacing (atp) had been programmed off at that time.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that following a routine device changeout, this right ventricular (rv) lead exhibited non-capture.The newly implanted cardiac resynchronization therapy defibrillator (crt-d) was programmed to left ventricular (lv) only pacing and anti-tachycardia pacing (atp) was programmed off.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that this right ventricular (rv) defibrillation lead had exhibited loss of capture (loc) since 2021 and anti-tachycardia pacing (atp) had been programmed off at that time.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that this rv lead exhibited a gradual rise to high out-of-range pace impedance measurements greater than 2,000 ohms since 2024, with a recent measurement of 2,600 ohms.There was no indication of lead noise on stored episodes, and it was noted that the rv was programmed to maximum outputs.Technical services (ts) discussed troubleshooting options.This rv lead remains in service.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20471287
• Report Number: 2124215-2024-65013
• Device Sequence Number: 15360941
• Product Code: NVY
• UDI-Device Identifier: 00802526431371
• UDI-Public: (01)00802526431371(17)200301(21)419841
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/01/2020
• Device Model Number: 0282
• Device Catalogue Number: 0282
• Device Lot Number: 419841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 02/11/2026
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/01/2024; 02/25/2026
• Date Device Manufactured: 03/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female