BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1881265 · Received October 6, 2010

    Report

    Report Number
    1644487-2010-02238
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "VNS APPARATUS" WOULD NOT REMAIN ON ONCE TURNED ON. IT WAS DETERMINED THAT THE SUSPECT COMPONENT WAS THE HANDHELD. IT WAS REPORTED THAT THERE WAS NO MISHANDLING OF THE DEVICE, THE HANDHELD WAS PLUGGED IN WHEN NOT IS USE AND REMAINED ON A DESK AWAY FROM HEAT SOURCES. A NEW HANDHELD WAS SENT TO THE SITE. SITE WAS INSTRUCTED TO ALLOW THE HANDHELD TIME TO CHARGE AND CONNECT THE WAND TO THE NEW HANDHELD TO CONFIRM CONNECTION AND TO INFORM MANUFACTURER IF THERE WERE ANY PROBLEMS. THERE HAVE BEEN NO ADD'L REPORTS OF PROBLEMS. THE HANDHELD AND FLASHCARD IN QUESTION HAVE BEEN RETURNED TO THE MFR AND ARE CURRENTLY UNDERGOING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521383

    Patients

    Seq Age Sex Outcome Treatment
    1