BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3833692 · Received May 27, 2014

    Report

    Report Number
    1644487-2014-01369
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE HANDHELD DEVICE PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED HANDHELD DEVICE WAS COMPLETED. NO ANOMALIES ASSOCIATED WITH THE HANDHELD 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 FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROLOGIST WAS HAVING COMMUNICATION ISSUES WITH HIS HANDHELD DEVICE. THE HANDHELD DEVICE WAS UNPLUGGED FROM THE WALL AND THE WAND BATTERY WAS REPLACED. THE NEUROLOGIST¿S PROGRAMMING WAND WAS TESTED USING A DIFFERENT HANDHELD DEVICE AND HIS HANDHELD DEVICE WAS TESTED USING A DIFFERENT PROGRAMMING WAND. THE COMMUNICATION ISSUES WERE ISOLATED TO THE HANDHELD DEVICE. THE HANDHELD DEVICE HAS BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310336 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1075663

    Patients

    Seq Age Sex Outcome Treatment
    1