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

Model Number	0296
Medical Device Problem Codes	Failure to Capture (1081); Low impedance (2285); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead had dropping impedance measurements that remained within normal limits along with high capture thresholds.There was intermittent capture for the rv lead as well as the left ventricular (lv) lead.Technical services (ts) reviewed and discussed both ventricular leads showed loss of capture (loc).Later it was noted the right atrial (ra) lead also exhibited loc.The patient was brought in for a lead revision, and the ra lead was attempted but unable to get acceptable parameters likely due to patient tissue.The physician instead decided to perform a generator changeout to maximize longevity for the leads, so the cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced.The physician also discussed future options for device placement with the patient.This rv lead remains in service.No additional 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): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25897188
• Report Number: 2124215-2026-39381
• Device Sequence Number: 10124471
• Product Code: NVY
• UDI-Device Identifier: 00802526531279
• UDI-Public: (01)00802526531279(17)181110
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

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: 11/10/2018
• Device Model Number: 0296
• Device Catalogue Number: 0296
• Device Lot Number: 395248
• 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: 06/23/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 11/10/2016
• 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: 81 YR
• Patient Sex: Male