BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2260286 · Received September 1, 2011

    Report

    Report Number
    1644487-2011-02016
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN'S OFFICE REPORTED THAT THE HAND-HELD DEVICE (HHD) USED AT THEIR SITE WAS NO LONGER HOLDING A CHARGE. DIFFERENT CORDS WERE USED TO CHARGE THE HHD AND IT WOULD STILL NOT HOLD A CHARGE. THE HHD WAS STORED IN A NORMAL OFFICE ENVIRONMENT AND IS LEFT PLUGGED IN AT ALL TIMES. THE PRODUCT'S RETURN IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 857133

    Patients

    Seq Age Sex Outcome Treatment
    1