BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 22898166 · Received August 26, 2025

    Report

    Report Number
    2124215-2025-59951
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    February 1, 2025
    Report Date
    August 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526422072
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHOCK LEAD IMPEDANCE (SLI) MEASUREMENTS OF 100-125 OHMS SINCE DEVICE UPGRADE AND MOST RECENTLY THE SLI REACHED 137 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PROVIDED TROUBLE SHOOTING RECOMMENDATIONS. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2779992 ENDOTAK RELIANCE G IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0185 00802526422072

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female