BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2193103 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01641
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 27, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAND-HELD DEVICE WOULD NOT RESPOND TO SCREEN TAPS WITH THE STYLUS. THE PHYSICIAN'S SITE HAD PERFORMED HARD RESETS ON THE DEVICE, BUT THE ISSUE WAS NOT RESOLVED. THE FLASHCARD WAS STATED TO BE FULLY SEATED. THE PRODUCT'S RETURN IS EXPECTED, BUT HAS NOT OCCURRED TO DATE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1