BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1061891 · Received June 16, 2008

    Report

    Report Number
    1644487-2008-01384
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE HAND HELD COULD NOT BE CHARGED COMPLETELY, AND THAT THE BATTERY WAS COMPLETELY DEPLETED AFTER FIVE MINUTES OF USAGE WHEN UNPLUGGED FROM THE WALL OUTLET. THE HAND HELD HAS BEEN RETURNED TO MANUFACTURER AND ANALYSIS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 523503

    Patients

    Seq Age Sex Outcome Treatment
    1