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

Model Number	0180
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a nonspecific product performance anomaly.Subsequently, this lead was explanted and replaced.This product has not been returned for analysis.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a nonspecific product performance anomaly.Subsequently, this lead was explanted and replaced.This product has not been returned for analysis.No additional adverse patient effects were reported.Additional information was received from the field indicating this lead was explanted and replaced due to fractur.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product was explanted and was not returned; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Additional Manufacturer Narrative
Updated record with additional information indicating this lead exhibited fracture.This product was explanted and was not returned; therefore, a technical analysis could not be performed.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 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50100695
• Report Number: 2124215-2026-41274
• Device Sequence Number: 13341661
• Product Code: LWS
• UDI-Device Identifier: 00802526531149
• UDI-Public: (01)00802526531149(17)160730
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2026

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: 07/30/2016
• Device Model Number: 0180
• Device Catalogue Number: 0180
• Device Lot Number: 311105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 07/31/2026; 09/17/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/03/2026; 09/18/2026
• Date Device Manufactured: 07/30/2014
• 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: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male