BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2840699 · Received November 20, 2012

    Report

    Report Number
    1644487-2012-03086
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT WHILE ATTEMPTING TO UPGRADE THE PHYSICIAN'S HANDHELD THAT AN ERROR MESSAGE(S) WERE RECEIVED WHILE ATTEMPTING TO UPGRADE THE HANDHELD TO A NEW SOFTWARE VERSION. IT IS UNCLEAR WHAT THE SPECIFIC ERROR MESSAGE WAS THAT WAS RECEIVED. THE HANDHELD, BOTH THE OLD (V8.0) AND NEW (V8.1) SOFTWARE VERSION FLASHCARDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. GOOD FAITH ATTEMPT FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE HANDHELD AND BOTH SOFTWARE VERSION FLASHCARDS. NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ANOMALIES ASSOCIATED WITH 8.0 FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. BASED ON TESTING IN THE PA LAB THE UPGRADE ISSUES IDENTIFIED WITH THE 8.1 FLASHCARD CAN BE ASSOCIATED WITH A VARIETY OF FACTORS INCLUDING NOT SELECTING THE "OK" BUTTON IF ASKED TO ACKNOWLEDGE THAT SOME OF THE V8.0 FILES WERE NOT UNINSTALLED, ATTEMPTING TO START THE UPGRADE PROCESS IN THE USER PREFERENCES WINDOW WHEN THE DATABASE UTILITIES BUTTON IS GREYED OUT, CYCLING THE FLASHCARD (PERHAPS WHILE TROUBLESHOOTING) AFTER THE 8.1 UPGRADE HAS STARTED. DURING THE ANALYSIS, NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE RETURNED HANDHELD WAS UPGRADED USING THE SOFTWARE INSTALLATION INSTRUCTION GUIDE WITH NO ISSUES. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1063529

    Patients

    Seq Age Sex Outcome Treatment
    1