BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1083207 · Received July 24, 2008

    Report

    Report Number
    1644487-2008-01687
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE SITE'S DELL HANDHELD COMPUTER SCREEN WAS FREEZING. THE HANDHELD COMPUTER HAS BEEN RETURNED TO MANUFACTURER FOR ANALYSIS, AND A NEW HANDHELD COMPUTER HAS BEEN SEND TO THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 523499

    Patients

    Seq Age Sex Outcome Treatment
    1