MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	0184
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.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 this right ventricular (rv) defibrillation lead exhibited high out-of-range shock impedance measurements greater than 200 ohms on the superior vena cava (svc) coil.Distal coil to can had an in-range shock impedance measurement of 80 ohms.Technical services (ts) discussed troubleshooting options and programming considerations.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and lead return status.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 this right ventricular (rv) defibrillation lead exhibited high out-of-range shock impedance measurements greater than 200 ohms on the superior vena cava (svc) coil.Distal coil to can had an in-range shock impedance measurement of 80 ohms.Technical services (ts) discussed troubleshooting options and programming considerations.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that this rv lead was explanted and replaced, and the non boston scientific cardiac resynchronization therapy defibrillator (crt-d) was also explanted and replaced due to therapy upgrade/downgrade during the same procedure.No additional adverse patient effects were reported.Product return was requested.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 23341215
• Report Number: 2124215-2025-74724
• Device Sequence Number: 7742815
• Product Code: LWS
• UDI-Device Identifier: 00802526531187
• UDI-Public: (01)00802526531187(17)150708
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/19/2025

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: 07/08/2015
• Device Model Number: 0184
• Device Catalogue Number: 0184
• Device Lot Number: 325797
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 07/08/2013
• 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: 72 YR
• Patient Sex: Female