BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2260287 · Received September 1, 2011

    Report

    Report Number
    1644487-2011-02024
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN'S OFFICE THAT THEIR HAND-HELD DEVICE (HHD) WAS NOT ALLOWING THEM TO ALIGN THE SCREEN. LATER, THE HHD WOULD NOT TURN ON. WHEN A HARD RESET WAS PERFORMED, THE HHD BECAME FROZEN ON THE "CLEAR ALL DATA" SCREEN. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 839583

    Patients

    Seq Age Sex Outcome Treatment
    1