BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1840037 · Received September 15, 2010

    Report

    Report Number
    1644487-2010-02097
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN'S DELL X5 HANDHELD DEVICE WOULD NOT HOLD A CHARGE AND HE IS UNABLE TO INTERROGATE AND PROGRAM PTS' DEVICES AS IT WILL ONLY STAY ON FOR A FEW SECONDS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO ARE CURRENTLY BEING MADE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1