BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINAL CORD STIMULATOR

    MDR report key: 381523 · Received March 9, 2002

    Report

    Report Number
    MW1024338
    Event Type
    Other
    Date Received
    March 9, 2002
    Date of Event
    February 18, 2000
    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

    INABILITY TO PRODUCE STIMULATIONS BY THE IMPLANTED SPINAL CORD STIMULATOR RESULTING IN SEVERE PAIN AND DISABILITY. THE EXPLANTED SYSTEM REVEALED SIGNS OF CORROSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other