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

Model Number	0138
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Material Integrity Problem (2978)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) and this right ventricular (rv) lead delivered inappropriate anti-tachycardia pacing (atp) and a single shock due to oversensing of noise.The patient had a strong underlying rhythm, and no pacing inhibition was noted.The field representative (rep) didn't know what the patient was doing when the noise was recorded.Technical services (ts) discussed troubleshooting options to reproduce the noise and recommended asking what the patient was doing at the time of the shock.This rv lead remains in service.No adverse patient effects were reported.Additional information was received from the field.The patient was seen in clinic and the physician suspected subclavian crush.The icd was explanted and replaced.This rv lead was surgically abandoned and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information added to b5.B1, b2, f10, h1, and h6 updated.This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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; EI 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50326257
• Report Number: 2124215-2026-44647
• Device Sequence Number: 21240706
• Product Code: LWS
• UDI-Device Identifier: 00802526531118
• UDI-Public: (01)00802526531118(17)241005
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 10/05/2024
• Device Model Number: 0138
• Device Catalogue Number: 0138
• Device Lot Number: 305194
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 10/05/2022
• 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: 28 YR
• Patient Sex: Female