BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1220049 · Received October 31, 2008

    Report

    Report Number
    1644487-2008-02647
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN'S HANDHELD DEVICE WOULD NOT HOLD A CHARGE. THE HANDHELD WOULD ONLY TURN ON WHEN PLUGGED INTO THE WALL AND ONCE UNPLUGGED, THE DEVICE WOULD TURN OFF. THE HANDHELD WAS REPLACED AND THE OLD DEVICE WAS SENT TO THE MANUFACTURER FOR ANALYSIS. EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 584947

    Patients

    Seq Age Sex Outcome Treatment
    1