BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2170955 · Received June 30, 2011

    Report

    Report Number
    1644487-2011-01437
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A SOFTWARE UPGRADE, A COMPANY REP WAS UNABLE TO LOCATE THE DIRECTORY FOLDER IN THE VNS SOFTWARE TO INITIATE THE UPGRADE PROCESS. A NEW CARD WAS SUBSTITUTED INTO THE DEVICE AND THE UPGRADE PROCEEDED AS INTENDED. 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 868257

    Patients

    Seq Age Sex Outcome Treatment
    1