BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINAL CORD STIMULATOR

    MDR report key: 381526 · Received March 9, 2002

    Report

    Report Number
    MW1024339
    Event Type
    Other
    Date Received
    March 9, 2002
    Date of Event
    May 22, 1995
    Report Date
    March 9, 2002
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SPINAL CORD STIMULATOR LEAD WAS VERY STIFF RESULTING IN EROSION OF THE SKIN OVER THE LEAD. THIS SITUATION RESULTED IN ADDITIONAL SURGERY: REMOVAL OF THE DEFECTIVE SYSTEM AND IMPLANTATION OF A NEW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL CORD STIMULATOR * GZB ADVANCED NEUROMODULATION SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other