BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED NEUROMODULATION SYSTEMS, INC. -ANS-

    MDR report key: 550200 · Received August 3, 2004

    Report

    Report Number
    MW1032923
    Event Type
    Malfunction
    Date Received
    August 3, 2004
    Date of Event
    August 2, 2004
    Report Date
    August 3, 2004
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CABLE REF 3008 ADVANCED NEUROMODULATION SYSTEM LOT NUMBER 27397 FAILED TO CONDUCT, NECESSITATING REPLACEMENT USING A DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED NEUROMODULATION SYSTEMS, INC. -ANS- CABLE FOR SPINAL CORD STIMULATOR LEAD GZB ADVANCED NEUROMODULATION SYSTEMS, INC. REF 3008 27397

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other 2) TEST LEAD CABLES,| 3) PROBABLE RECEIVER PLACEMENT.| 1) PLANNED REMOVAL OF STIMULATOR,