BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1213118 · Received October 23, 2008

    Report

    Report Number
    1644487-2008-02547
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 29, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLASHCARD FILE WAS UNABLE TO BE UPLOADED DUE TO AN SQL ERROR. THE FLASHCARD WAS SENT TO THE PRODUCT ANALYSIS LAB FOR EVALUATION. UPON COMPLETION OF PRODUCT TESTING, IT WAS DETERMINED THAT THE EVENT WAS CAUSED BY A CORRUPT DATABASE. THE ANALYSIS COULD NOT DETERMINE THE INITIAL CAUSE OF THE DATABASE CORRUPTION, BUT THAT IT WAS MOST LIKELY ASSOCIATED WITH THE FLASHCARD. NO FURTHER ANOMALIES ASSOCIATED WITH THE FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE UNKNOWN LYJ CYBERONICS, INC. MODEL 250 366994

    Patients

    Seq Age Sex Outcome Treatment
    1