BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUROSTIMULATOR

    MDR report key: 4190278 · Received October 11, 2014

    Report

    Report Number
    MW5038693
    Event Type
    Other
    Date Received
    October 11, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    MHY
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A METRONIC NEUROSTIMULATOR IMPLANTED IN (B)(6) 2014 THEN MY LEGS BECAME WEAK, JOINTS FEEL LIKE I HAVE ARTHRITIS, HAD CHRONIC LOW GRADE TEMP, BURNING AT BATTERY AND PAIN EVERY WHERE LEADS, BATTERY AND PADDLE IMPLANTED, HAD SO MUCH WEAKNESS IN MY LEGS THAT I WAS HAVING TROUBLE WALKING AND HAD TO HAVE IT REMOVED AT ANOTHER FACILITY IN (B)(6) 2014 AND STILL HAVING ARTHRITIC SYMPTOMS AND BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645450 NEUROSTIMULATOR NONE MHY MEDTRONIC 37751

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR