BEUDAMED
    FDA Adverse Event Summary report: N

    SPINAL STIMULATOR

    MDR report key: 18863 · Received February 15, 1994

    Report

    Report Number
    MW4000607
    Date Received
    February 15, 1994
    Report Date
    February 15, 1994
    Manufacturer
    NEUROMED, INC.
    Product Code
    GZB
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT OF SEVERAL FAILURES OF RECEIVER KIT WITH 8 CHANNEL ANTENNA ADAPTOR. PT HAS HAD A SERIES OF PROBLEMS WITH THIS BACK PAIN DEVICE. DEVICE WAS REPLACED TWICE IN A YEAR AND A HALF. ON 6/23/92, ORIGINAL UNIT IMPLANTED; 11/25/92, REPAIRED ANTENNA; 3/29/93, REPAIRED ANTENNA AND STIMULATOR; 4/5/93, REPLACED ENTIRE NEURAL STIMULATOR KIT (THE FIRM REPLACED THE ENTIRE KIT AT NO CHARGE); 7/27/93, REPAIRED ANTENNA CONNECTOR; 8/9/93, REPLACED TRANSMITTER ANTENNA; 9/29/93, REPLACED ENTIRE NEURAL STIMULATOR KIT; 11/24/93, REPAIRED ANTENNA CONNECTOR; 12/7/93, RECEIVER IS NOT WORKING PROPERLY AGAIN AND IS GOING TO BE REPLACED. IN 4/94 AFTER THE NEW 16 CHANNEL MODEL IS APPROVED BY FDA. EACH NEURAL STIMULATOR KIT HAD TO BE REPLACED BECAUSE THE UNITS WERE SHOCKING THE PT. THE SHOCKING CAUSED SUCH SEVERE MUSCLE SPASMS THAT THE PT COULD NOT TURN THE UNIT OFF BY HERSELF. A FAMILY MEMBER HAD TO TURN IT OFF FOR HER. BECAUSE OF THAT FACT, THE PT PRESENTLY DOES NOT TURN THE UNIT ON WHEN SHE IS BY HERSELF. THE CURRENT UNIT IS EXHIBITING THE SAME PROBLEMS AS BEFORE AS WELL AS EXHIBITING PERIODS OF LOW CURRENT IMPULSES. THIS UNIT WILL ALSO HAVE TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL STIMULATOR SPINAL STIMULATOR RECEIVER KIT W/8 CHANNEL ANTENNA ADAPTOR GZB NEUROMED, INC. MNR88B

    Patients

    Seq Age Sex Outcome Treatment
    1 *