BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NEUROSTIMULATOR

    MDR report key: 1429345 · Received July 29, 2009

    Report

    Report Number
    MW5012136
    Event Type
    Malfunction
    Date Received
    July 29, 2009
    Date of Event
    May 28, 2009
    Report Date
    July 29, 2009
    Product Code
    EZW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE MEDTRONIC PROGRAMMER # 37743 FOR USE WITH NEUROSTIMULATOR. HAD QUIT WORKING IN 2009 WAS TURNED OFF, WAS NOT WORKING. HAD APPOINTMENT WITH UROLOGY AT ABOUT ONE MONTH LATER, AND & XRAYS SHOWED LEADS HAD COME LOOSE. HAVE BEEN CALLING MEDTRONIC PEOPLE, SINCE THEN & THEY KEEP PUTTING IT OFF, THEY HAVE TO RE EVALUATE ECT & NOTHING IS BEING DONE. I GET SPASMS WHEN I URINATE & I AM IN PAIN. DATES OF USE: 2009. DIAGNOSTICS OR REASON FOR USE: INCONTINENT. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC NEUROSTIMULATOR LIKE A PACE MAKER EZW 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other