BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4203562 · Received October 27, 2014

    Report

    Report Number
    1644487-2014-02840
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 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, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMING TABLET SCREEN WAS ACTING UP. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPANY REPRESENTATIVE FOLLOWED-UP WITH THE OFFICE AND IT WAS REPORTED THAT THE PHYSICIAN WAS NOT KEEPING THE TABLET PLUGGED IN WITH A GOOD CHARGE. AS A RESULT OF NOT KEEPING THE TABLET PLUGGED INTO A POWER OUTLET WHEN NOT IN USE, THE TABLET WOULD NOT HOLD A CHARGE. AFTER CHARGING, IT WAS FUNCTIONING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682666 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1