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

Model Number	0175
Medical Device Problem Codes	High impedance (1291); Failure to Convert Rhythm (1540)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Loss of consciousness (2418)
Date of Event	08/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead recorded a code 1005, indicative of an open circuit condition during shock delivery.The patient experienced a ventricular arrhythmia, during which therapy was exhausted, became unresponsive, and required hospitalization.The physician alleged that biventricular trigger caused the arrest.Technical services (ts) was consulted and reviewed the device data, noted shock impedance measurements were greater than 125 ohms.Ts explained that this is an advisory lead and the eight shocks delivered were unable to convert the arrhythmia episode.The timing on the premature ventricular contraction (pvc) and biventricular trigger fell at the end of the t-wave deflection appeared as the cause of the ventricular fibrillation (vf) arrest.Ts recommended lead replacement.No additional adverse patient effects were reported.This rv lead remains in service.

• 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: 22918155
• Report Number: 2124215-2025-60754
• Device Sequence Number: 9892585
• Product Code: LWS
• UDI-Device Identifier: 00802526373732
• UDI-Public: (01)00802526373732(17)121013
• 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: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: 10/13/2012
• Device Model Number: 0175
• Device Catalogue Number: 0175
• Device Lot Number: 138015
• 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: 08/09/2025
• Initial Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 10/13/2010
• 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; Life Threatening
• Patient Age: 52 YR
• Patient Sex: Female