BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL NERVE STIMULATOR

    MDR report key: 10903 · Received January 10, 1994

    Report

    Report Number
    MW1000353
    Event Type
    Malfunction
    Date Received
    January 10, 1994
    Date of Event
    March 15, 1991
    Report Date
    December 27, 1993
    Manufacturer
    NEUROMED, INC.
    Product Code
    GZB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USER WAS NOT INFORMED OF SAFETY DEVICE ON STIMULATOR. ON 3/15/91, USER AWOKE FROM SLEEPING, ATTEMPTED TO TURN STIMULATOR OFF, INSTEAD SHE TURNED IT UP AS HIGH AS IT COULD BE TURNED. SHE RECEIVED A HIGH BURST OF CURRENT AND WAS THROWN TO THE FLOOR, INJURYING HER LEFT HIP AND LEG. SHE COULD NOT MOVE HER LEFT HAND OR SIDE BUT DISCOVERED SHE COULD MOVE RIGHT HAND, SO SHE PULLED THE DEVICE FROM HER BODY STOPPING STIMULATION. THIS STIMULATOR SHOULD NOT BE ALLOWED TO BE PROGRAMMED WITH THAT HIGH OF A CURRENT. NO MATTER HOW BAD ONE'S PAIN IS THEY COULD NOT TOLERATE THAT AMOUNT OF STIMULATION. SAFETY DEVICE NOT DESCRIBED IN HANDBOOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL NERVE STIMULATOR Implant GZB NEUROMED, INC. MNT-4D

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other