BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1202208 · Received October 16, 2008

    Report

    Report Number
    1644487-2008-02490
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS SUSPECTED, BUT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THEY WERE HAVING PROBLEMS WITH THEIR DELL X50 HAND HELD COMPUTER NOT HOLDING A CHARGE. PER REPORTER, THE HAND HELD HAS BEEN CONSISTENTLY PLUGGED IN AND WHEN THEY UNPLUG IT, IT WILL NOT HOLD A CHARGE. PRODUCT HAS BEEN RETURNED TO MFR, BUT ANALYSIS IS PENDING.

    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