BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1041284 · Received May 9, 2008

    Report

    Report Number
    1644487-2008-01107
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS DELL X5 COMPUTER SCREEN WAS CONTINUOUSLY FREEZING DURING INTERROGATION. THE DELL X5 COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ARE CURRENTLY IN PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 530641

    Patients

    Seq Age Sex Outcome Treatment
    1