BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIPROGRAMMABLE NEUROSTIMULATOR RECEIVER

    MDR report key: 19677 · Received December 29, 1994

    Report

    Report Number
    19677
    Event Type
    Injury
    Date Received
    December 29, 1994
    Date of Event
    December 21, 1994
    Report Date
    December 29, 1994
    Manufacturer
    NEUROMED, INC.
    Product Code
    GZB
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD HAD LONG STANDING HISTORY OF BACK AND LEG PAIN REFRACTORY TO CONSERVATIVE CARE. PLACEMENT OF DORSAL COLUMN STIMULATOR HAD GIVEN TEMPORARY RELIEF, HOWEVER, THERE WAS MALFUNCTION AND/OR FAILURE OF THE DEVICE AS DETERMINED BY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPROGRAMMABLE NEUROSTIMULATOR RECEIVER Implant MULTIPROGRAMMABLE NEUROSTIMULATOR RECEIVER GZB NEUROMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention