MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; Implantable lead

Model Number	0292
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) system presented to the emergency room (er) and claimed they received shocks.It was noted the patient had been non-compliant, and data showed the device reached elective replacement indicator (eri) approximately eight months ago.It was also noted remote monitoring was disabled approximately three months ago.Technical services (ts) reviewed the data and confirmed the device was at end of life (eol) and there would be no way to see whether the patient received therapy.It was not determined whether the patient was shocked, and whether therapy was appropriate or not.Information from the field was received and noted there was a fracture in the right ventricular (rv) lead and that the patient may have received inappropriate shocks due to the noise on the lead from the fracture.It was also noted both brady and tachy therapy was turned off.The patient was scheduled to follow up with the physician.No additional adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: Implantable lead
• 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50610052
• Report Number: 2124215-2026-47256
• Device Sequence Number: 10634880
• Product Code: NVY
• UDI-Device Identifier: 00802526531248
• UDI-Public: (01)00802526531248(17)161021
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/21/2016
• Device Model Number: 0292
• Device Catalogue Number: 0292
• Device Lot Number: 334209
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 10/21/2014
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female