BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1203129 · Received October 17, 2008

    Report

    Report Number
    1644487-2008-02519
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 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

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    RPTR INDICATED SQL ERRORS WERE NOTED WHILE ATTEMPTING TO UPLOAD FLASHCARD INFORMATION. AN ANALYSIS WAS PERFORMED ON THE FLASHCARD AND THE CAUSE FOR THE SQL ERROR IS ASSOCIATED WITH A CORRUPT DATABASE. AFTER THE ANALYSIS WAS COMPLETED, THE FLASHCARD WAS NOT UPDATED SO THE LAST KNOWN GOOD DATABASE COULD BE UPLOADED. AS A RESULT, THE VNS SOFTWARE ATTEMPTED TO READ THE CORRUPT CYBERONICS BU/CDB DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 282996

    Patients

    Seq Age Sex Outcome Treatment
    1