BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1181593 · Received September 25, 2008

    Report

    Report Number
    1644487-2008-02346
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THEIR HANDHELD WAS NOT ABLE TO COMMUNICATE WITH THE PATIENT'S GENERATOR AND WAS FREEZING UPON INTERROGATION. THE HANDHELD CONTAINED 7.1 PROGRAMMING SOFTWARE. THE HANDHELD WAS UNPLUGGED AND THE AFTER A FLASHCARD REINSERTION WITH SOFT RESET THE PATIENT WAS REINTERROGATED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 523496

    Patients

    Seq Age Sex Outcome Treatment
    1