BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2062218 · Received April 11, 2011

    Report

    Report Number
    1644487-2011-00767
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN TO A PHYSICIAN'S DELL X5 HANDHELD DEVICE WAS FROZEN AT THE "INTERROGATION SUCCESSFUL" SCREEN. THE PHYSICIAN PERFORMED A HARD RESET AND THE HANDHELD WORKED PROPERLY. NO REPLACEMENT PRODUCT WAS REQUESTED AS THE ISSUE RESOLVED WITH TROUBLESHOOTING.

    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