BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL STIMULATOR

    MDR report key: 1003959 · Received February 25, 2008

    Report

    Report Number
    MW5005689
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 25, 2008
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES THAT SHE WENT FOR PHYSICAL THERAPY AND THE PT ASSISTANT PLACED LEADS ON HER SPINE, SHE FEELS THAT SHE MAY HAVE LOST CONSCIOUSNESS AND THAT HER HAND AND FOOT LOST FEELING ALONG WITH HER ARM AND BUTTOCKS. PATIENT STATES THAT THE FEELING WAS AS IF SHE WAS HAVING ANOTHER STROKE, AND SHE NOW HAS HEART PALPITATIONS AND SHORTNESS OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL STIMULATOR NONE GZB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR