BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 12185139 · Received July 16, 2021

    Report

    Report Number
    2124215-2021-19399
    Event Type
    Injury
    Date Received
    July 16, 2021
    Date of Event
    January 3, 2021
    Report Date
    July 16, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526531262
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE THAT WAS BEING OVERSENSED BY THE RIGHT VENTRICLE (RV) LEAD. THE NOISE WAS DUE TO MYOPOTENTIAL. ADDITIONALLY, THERE WAS A DROP IN PACING IMPEDANCES THAT WENT FROM 800-400 OHMS. TECHNICAL SERVICES RECOMMENDED TO BRING THE PATIENT IN TO EVALUATE THE LEAD. THE PATIENT WAS EVALUATED AND A CHEST X-RAY WAS PERFORMED AND IT APPEARS THE RV LEAD WAS DISLODGED. IT WAS NOTED IT MAY BE DUE TO TWIDDLERS SYNDROME. THE PATIENT ELECTED NOT TO HAVE SURGERY AS A RESULT THERAPY WAS PROGRAMMED OFF. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076073 ENDOTAK RELIANCE G IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 0295 389790 00802526531262

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other