BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORSAL COLUMN STIMULATOR

    MDR report key: 2081808 · Received May 3, 2011

    Report

    Report Number
    MW5020510
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    January 28, 2011
    Report Date
    May 3, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BLISTERING, SEVERE ITCHING, PERMANENT SCARRING, EXACERBATED ASTHMA, INCREASED PAIN, AND EXACERBATED MY RSD. BLISTERING EVENTUALLY CLEARED UP, HOWEVER, SEVERE ITCHING IS STILL ON GOING EVEN TAKING ATARAX THREE TIMES A DAY. NOTHING SEEMS TO STOP THE ITCHING. THE DEVICE THAT WAS IMPLANTED TO HELP RELIEVE SEVERE CHRONIC PAIN, IS NOT HELPING RELIEVE MY PAIN AND I AM NOW TAKING ADDITIONAL MEDICINES TO HELP MANAGE THE PAIN. IN FACT, MY PAIN HAS INCREASED SINCE THE DEVICE WAS IMPLANTED. SINCE I TURNED OFF THE DEVICE, MY PAIN HAS GONE DOWN SOME, BUT IS STILL ABOVE THAT IT WAS BEFORE THE DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORSAL COLUMN STIMULATOR STIMULATION DEVICE GZB MEDTRONIC 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability