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

Model Number	0171
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Low impedance (2285); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with a non-boston scientific device and this right ventricular (rv) lead, had a ventricular tachycardia (vt) episode.A shock was delivered but there was not enough energy to revert the rhythm as the shock impedance measurements were low out of range at that moment.Patient had to be externally rescued.The patient had a second ventricular tachycardia (vt) episode, and an appropriate anti-tachycardia pacing (atp) was delivered which converted the arrhythmia.Technical services (ts) suspected possible lead damage and calcification.A lead replacement was recommended.No additional adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
At this time, no further information is available.Should additional information become available this report will be updated.
Additional Manufacturer Narrative
Follow up 1 (additional information): this report is being submitted to update the section b5 and h6 device codes.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the patient with a non-boston scientific device and this right ventricular (rv) lead, had a ventricular tachycardia (vt) episode.A shock was delivered but there was not enough energy to revert the rhythm as the shock impedance measurements were low out of range at that moment.Patient had to be externally rescued.The patient had a second ventricular tachycardia (vt) episode, and an appropriate anti-tachycardia pacing (atp) was delivered which converted the arrhythmia.Technical services (ts) suspected possible lead damage and calcification.A lead replacement was recommended.No additional adverse patient effects were reported.This rv lead remains in service.Additional information indicated that there was a clear insulation breach.As a result, this lead was explanted and replaced with a none boston scientific lead.No additional adverse patient effects were reported.This lead has not been returned.

• 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: 23306110
• Report Number: 2124215-2025-73570
• Device Sequence Number: 20280891
• Product Code: LWS
• UDI-Device Identifier: 00802526373374
• UDI-Public: (01)00802526373374(17)170116
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: 01/16/2017
• Device Model Number: 0171
• Device Catalogue Number: 0171
• Device Lot Number: 104320
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/06/2025
• Date Device Manufactured: 01/16/2015
• 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; Other
• Patient Age: 59 YR
• Patient Sex: Male