MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE LEAD

Model Number	0283
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high capture thresholds and a gradual increase in high out of range pacing impedance measurements, measuring greater than 2000 ohms.Technical services (ts) noted there was a change in the tip tissue interface.No adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being submitted as additional information was received that the patient will continue to be monitored.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 (rv) lead exhibited high capture thresholds and a gradual increase in high out of range pacing impedance measurements, measuring greater than 2000 ohms.Technical services (ts) noted there was a change in the tip tissue interface.The patient will continue to be monitored.No adverse patient effects were reported.This rv lead remains in service.

• 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24259758
• Report Number: 2124215-2026-06419
• Device Sequence Number: 7894061
• Product Code: NVY
• UDI-Device Identifier: 00802526431388
• UDI-Public: (01)00802526431388(17)190406
• 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: 2017
• 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): 05/19/2026

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: 04/06/2019
• Device Model Number: 0283
• Device Catalogue Number: 0283
• Device Lot Number: 396630
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 01/20/2026; 05/18/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/04/2026; 05/19/2026
• Date Device Manufactured: 04/06/2017
• 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: 60 YR
• Patient Sex: Male