BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4103274 · Received September 19, 2014

    Report

    Report Number
    1644487-2014-02413
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HANDHELD WAS RETURNED FOR ANALYSIS. ANALYSIS WAS COMPLETED ON 10/21/2014. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WOULD NOT POWER ON WHEN PLUGGED INTO AN ELECTRICAL OUTLET. IT WAS REPORTED THAT THE BATTERY LIGHT ILLUMINATED AMBER WHEN PLUGGED IN. A HARD RESET WAS PERFORMED AND THE SCREEN LOCK WAS NOT ENGAGED. IT WS REPORTED THAT THE HANDHELD WOULD NOT RESET. IT WAS LATER REPORTED THAT THE HANDHELD WAS ABLE TO BE POWERED ON, BUT THAT THE HANDHELD FROZE AND ANOTHER HARD RESET DID NOT RESOLVE THE ISSUE. THE PHYSICIAN WAS PROVIDED A NEW PROGRAMMING TABLET. THE HANDHELD IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581721 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1