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

Model Number	0175
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
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 this right ventricular (rv) lead exhibited a gradual increase in pacing impedance measurements.Pacing impedance measurements are now high out of range.This rv lead remains in service.No adverse patient effects were reported.
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 this right ventricular (rv) lead exhibited a gradual increase in pacing impedance measurements.Pacing impedance measurements are now high out of range.Additional information provided this rv lead was subsequently explanted.Another rv lead was implanted to complete this procedure.Additional information from the field representative provided this rv lead was fractured.The fracture resulted in reproducible noise which was oversensed.The field representative also reported there had been non-conversion of ventricular tachycardia (vt) and ventricular fibrillation (vf) due to this rv lead fracture.Additional information from the field representative provided there was no evidence of non-conversion of vt or vf.This rv lead has not been returned.No additional adverse patient effects were reported.
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 this right ventricular (rv) lead exhibited a gradual increase in pacing impedance measurements.Pacing impedance measurements are now high out of range.Additional information provided this rv lead was subsequently explanted.Another rv lead was implanted to complete this procedure.This rv lead has not been returned at this time.No additional adverse patient effects were reported.
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 this right ventricular (rv) lead exhibited a gradual increase in pacing impedance measurements.Pacing impedance measurements are now high out of range.Additional information provided this rv lead was subsequently explanted.Another rv lead was implanted to complete this procedure.Additional information from the field representative provided this rv lead was fractured.The fracture resulted in reproducible noise which was oversensed.The field representative also reported there had been non-conversion of ventricular tachycardia and ventricular fibrillation due to this rv lead fracture.Additional information has been requested but was not provided at this time.This rv lead has not been returned.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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23134244
• Report Number: 2124215-2025-67228
• Device Sequence Number: 9857662
• Product Code: LWS
• UDI-Device Identifier: 00802526373732
• UDI-Public: (01)00802526373732(17)170625
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/04/2025

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: 06/25/2017
• Device Model Number: 0175
• Device Catalogue Number: 0175
• Device Lot Number: 141963
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 10/15/2025; 11/03/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/17/2025; 11/03/2025; 11/04/2025
• Date Device Manufactured: 06/25/2015
• 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: 62 YR
• Patient Sex: Male