BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1203396 · Received October 15, 2008

    Report

    Report Number
    1644487-2008-02506
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSERTING A NEW FLASHCARD INTO A HANDHELD COMPUTER, AN SQL ERROR MESSAGE WAS OBSERVED. ANOTHER FLASHCARD WAS INSERTED WITH THE SAME RESULT. FOLLOWUP WITH THE COMPANY REPRESENTATIVE WHO HAD OBSERVED THE ERROR REVEALED THAT HE WAS TRYING TO MIGRATE THE DATABASE FROM AN OLD HANDHELD COMPUTER TO THE NEW HANDHELD. THAT WAS THE REASON FOR INSERTING A DIFFERENT FLAHSCARD INTO THE NEW HANDHELD. THE HANDHELD WAS IN THE SOFTWARE "TOP MENU" WHEN THE HANDHELD COMPUTER'S ORIGINAL FLASHCARD WAS FIRST REMOVED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED THAT THE FLASHCARD WAS ISSUED A YEAR PRIOR TO THE HANDHELD, INDICATING THE FLASHCARD WAS LIKELY USED IN A DIFFERENT MODEL HANDHELD. THIS SITUATION WILL PRODUCE THE SQL ERROR. GOOD FAITH ATTEMPTS TO OBTAIN THE PRODUCT FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 537100

    Patients

    Seq Age Sex Outcome Treatment
    1