BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINAL CORD STIMULATOR

    MDR report key: 381539 · Received March 9, 2002

    Report

    Report Number
    MW1024341
    Event Type
    Other
    Date Received
    March 9, 2002
    Date of Event
    September 9, 1996
    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

    INTERMITTENT AND INADEQUATE STIMULATION BY THE IMPLANTED SPINAL CORD STIMULATOR. MULTIPLE ATTEMPTS TO REPROGRAM THE SYSTEM DID NOT RESULT IN ANY IMPROVEMENT. THE PT HAD TO HAVE A SECOND SURGERY WHICH REVEALED LOSS OF ISOLATION AND SHREDDING OF THE LEADS.

    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 26 YR Other