BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 609386 · Received May 24, 2005

    Report

    Report Number
    609386
    Event Type
    Malfunction
    Date Received
    May 24, 2005
    Date of Event
    May 24, 2005
    Report Date
    May 24, 2005
    Manufacturer
    FHC INC.
    Product Code
    GZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A MICROTARGETING ELECTRODE WAS USED DURING A DEEP BRAIN STIMULATION CASE. WHEN USED, HIGH IMPEDENCE WAS NOTED WHICH CREATED EXCESSIVE NOISE ON THE MICRO ELECTRODE RECORDING UNIT. ANOTHER ELECTRODE WAS USED SUCCESSFULLY FROM THE SAME LOT. THIS SAME THING HAPPENED LAST WEEK. THE ELECTRODES WERE GIVEN BACK TO THE REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ELECTRODE ELECTRODE GZL FHC INC. * 116108

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR