BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 16797258 · Received April 24, 2023

    Report

    Report Number
    2124215-2023-19514
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    December 28, 2016
    Report Date
    April 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526373732
    PMA / PMN Number
    P910073/S041
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS, MEASURING BETWEEN 150-190 OHMS OVER THE LAST YEAR. TECHNICAL SERVICES PROVIDED TROUBLESHOOTING OPTIONS. SUBSEQUENTLY, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519766 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0175 00802526373732

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention