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

Model Number	0175
Medical Device Problem Codes	Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Low impedance (2285)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
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 this right ventricular lead exhibited low amplitude and noise, along with low out of range shock impedance measurements.An inappropriate shock was delivered due to atrial fibrillation with rapid ventricular response.After this, a code 1004 indicative of a short circuit condition detected during shock delivery was displayed.Replacement of the device and lead was recommended.Athis time, this lead remains in service.No further adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: Implantable lead
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - Del Caribe; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 24562926
• Report Number: 2124215-2026-13275
• Device Sequence Number: 21215192
• Product Code: LWS
• UDI-Device Identifier: 00802526373732
• UDI-Public: (01)00802526373732(17)060326
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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: 03/26/2006
• Device Model Number: 0175
• Device Catalogue Number: 0175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 03/26/2004
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female