MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Endotak Reliance; Implantable Lead

Model Number	0263
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
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 the patient with this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead experienced a syncopal episode.Technical services (ts) was consulted and noted undersensing, which resulted in the rhythm remaining below the rate cutoff (rco) criteria required for therapy delivery.Ts provided troubleshooting recommendations and advised consideration of rv lead revision to optimize sensing performance.This icd and rv lead remain in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead experienced a syncopal episode.Technical services (ts) was consulted and noted undersensing, which resulted in the rhythm remaining below the rate cutoff (rco) criteria required for therapy delivery.Ts provided troubleshooting recommendations and advised consideration of rv lead revision to optimize sensing performance.This icd and rv lead remain in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.\ \ a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.\ \ based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• Brand Name: Endotak Reliance
• 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: 25774540
• Report Number: 2124215-2026-37038
• Device Sequence Number: 21240784
• Product Code: NVY
• UDI-Device Identifier: 00802526601835
• UDI-Public: (01)00802526601835(17)250228
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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: 02/28/2025
• Device Model Number: 0263
• Device Catalogue Number: 0263
• Device Lot Number: 100670
• 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: 06/19/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 02/28/2023
• 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: 26 YR
• Patient Sex: Female