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

Model Number	0147
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a retrospective review of device data it was identified that during a shock delivery, this system recorded a code 1005 indicative of high, out-of-range shock impedance measurements greater than 145 ohms.This rv lead was surgically abandoned.No adverse patient effects were reported.
Additional Manufacturer Narrative
This correction report is being submitted to provide updated impact codes in h6.
Event or Problem Description
It was reported that during a retrospective review of device data it was identified that during a shock delivery, this system recorded a code 1005 indicative of high, out-of-range shock impedance measurements greater than 145 ohms.This rv lead was surgically abandoned.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: IMPLANTABLE DEFIBRILLATOR 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: 21862309
• Report Number: 2124215-2025-24670
• Device Sequence Number: 4593652
• Product Code: LWS
• UDI-Device Identifier: 00802526085789
• UDI-Public: (01)00802526085789(17)120112
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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: 01/12/2012
• Device Model Number: 0147
• Device Catalogue Number: 0147
• Device Lot Number: 117940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 01/12/2010
• 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; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male