BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2258012 · Received August 25, 2011

    Report

    Report Number
    1644487-2011-01963
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT THE HAND-HELD DEVICE'S (HHD) BATTERY LATCH IS OPEN AND WOULD NOT CLOSE BECAUSE THE BATTERY WAS "WARPED". CONSEQUENTLY, THE HHD WAS NOT ABLE TO BE USED. THE HHD WAS COMMONLY STORED ON THE TOP OFFICE COUNTER AND WAS NOT INVOLVED IN ANY RECENT MISHANDLINGS. THE PRODUCT'S RETURN IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 840144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown