BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2062216 · Received April 11, 2011

    Report

    Report Number
    1644487-2011-00768
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 15, 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 THAT A PHYSICIAN'S DELL X5 HANDHELD DEVICE WOULD REPEATEDLY FREEZE ON THE "INTERROGATION SUCCESSFUL" SCREEN. THE PHYSICIAN HAS BEEN ABLE TO TROUBLESHOOT PAST THE ISSUE; HOWEVER, GIVEN THE INCREASED FREQUENCY OF THE SCREEN FREEZE, HE WOULD LIKE IT REPLACED. A REPLACEMENT HANDHELD HAS BEEN SENT TO THE PHYSICIAN AND ATTEMPTS TO HAVE THE HANDHELD AND FLASHCARD IN QUESTION RETURNED TO THE MFR FOR ANALYSIS 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