BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE CARDIAC PACEMAKER

    MDR report key: 11071904 · Received December 23, 2020

    Report

    Report Number
    MW5098515
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Report Date
    December 21, 2020
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE HAD SOME PROBLEMS WITH QUICK BATTERY DEPLETION AND GOING FROM NEEDING THE PACEMAKER 18% TO NEEDING IT 54% IN JUST 8 MONTHS. I THINK IT'S A MALFUNCTION IN THE PACEMAKER CAUSING IT TO APPEAR AS THOUGH I NEED IT MORE. AS I HAVE ONLY HAD MINIMAL CHANGE SINCE BEING IMPLANTED IN 2012. AT A (B)(6) 2020 APPOINTMENT I WAS USING IT 18%, BY (B)(6)2020 IT WAS 32% AND NOW (B)(6) 2020 54%. IN (B)(6) 2020 I HAD 5 YRS ON THE BATTERY 3 MONTHS LATER, I HAVE 6 MONTHS ON THE BATTERY AND AM HAVING REPLACEMENT SURGERY IN (B)(6) 2021. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533359 ST JUDE CARDIAC PACEMAKER PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR