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

Model Number	0137
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this brady lead was an attempted implant due to unknown product performance anomaly.A new lead with the same model was implanted.No adverse patient effects were reported.The lead was returned for analysis.

• Brand Name: ENDOTAK RELIANCE S
• 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: 50943680
• Report Number: 2124215-2026-51918
• Device Sequence Number: 16063826
• Product Code: LWS
• UDI-Device Identifier: 00802526531101
• Combination Product (Y/N): Y
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Health Professional
• Device Model Number: 0137
• Device Catalogue Number: 0137
• Device Lot Number: 301854
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 04/16/2025
• 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: 81 YR
• Patient Sex: Unknown