BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1062986 · Received June 18, 2008

    Report

    Report Number
    1644487-2008-01407
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE SITE'S (B) (4) HANDHELD COMPUTER BATTERY WOULD NOT CHARGE. IT WAS REPORTED THAT TROUBLESHOOTING HAD BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. MODEL 250 584948

    Patients

    Seq Age Sex Outcome Treatment
    1