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

Model Number	0148
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a high out of range shock impedance, greater than 200 ohms, and there were no threshold measurements when connected to the icd.This occurred during an implantable cardioverter defibrillator (icd) implant procedure.The physician checked the leads were in the correct ports and reinserted into the header.A shock was attempted and this rv lead exhibited code 1005, indicative of an open circuit condition during shock delivery.The shock electrogram (egm) was flat.It was suspected that the distal coil conductor was broken when the physician manipulated the connections.This rv lead was surgically abandoned and replaced.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22699363
• Report Number: 2124215-2025-53769
• Device Sequence Number: 18429256
• Product Code: LWS
• UDI-Device Identifier: 00802526085918
• UDI-Public: (01)00802526085918(17)031203
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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: 12/03/2003
• Device Model Number: 0148
• Device Catalogue Number: 0148
• 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: 07/18/2025
• Initial Report FDA Received Date: 08/04/2025
• Date Device Manufactured: 12/03/2001
• 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: 48 YR
• Patient Sex: Male