BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1052419 · Received May 21, 2008

    Report

    Report Number
    1644487-2008-01189
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A HP JORNADA VNS HANDHELD COMPUTER WAS GIVING SQL ERRORS. THE ERROR READ "VNS THERAPY ERROR, ERROR EXECUTING SQL" FOLLOWED BY "LINES AND LINES OF TEXT". SOFT AND HARD RESETS DID NOT RESOLVE THE ERRORS. THE HANDHELD COMPUTER AND FLASHCARD HAVE BEEN REQUESTED FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 553964

    Patients

    Seq Age Sex Outcome Treatment
    1