BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4133273 · Received October 1, 2014

    Report

    Report Number
    1644487-2014-02530
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WAS FREEZING AT DIFFERENT TIMES. IT WAS REPORTED THAT THE PHYSICIAN FEELS THAT THE HANDHELD IS DIFFICULT TO USED BECAUSE OF THE FREEZING AND WOULD LIKE A NEW PROGRAMMING TABLET.THE PHYSICIAN WAS PROVIDED A NEW PROGRAMMING TABLET. THE HANDHELD WAS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE HANDHELD DEVICE AND SOFTWARE FLASHCARD WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. 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 FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611671 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1075844

    Patients

    Seq Age Sex Outcome Treatment
    1