BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 8758980 · Received July 3, 2019

    Report

    Report Number
    2124215-2019-12730
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    April 20, 2019
    Report Date
    July 3, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526531187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS NOTED TO HAVE FLUCTUATING PACING IMPEDANCE MEASUREMENTS BETWEEN 240-280 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THESE MEASUREMENTS ARE CONSIDERED OUT OF RANGE FOR THIS LEAD. WHILE THE POCKET WAS OPEN FOR THE DEVICE REPLACEMENT, THE PACE/SENSE PORTION OF THIS LEAD WAS SURGICALLY ABANDONED AND A PREVIOUS SURGICALLY ABANDONED RV PACE/SENSE LEAD WAS PLACED BACK IN SERVICE FOR PACING AND SENSING. THE SHOCK PORTION OF THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552927 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0184 321964 00802526531187

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR