BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1931686 · Received November 22, 2010

    Report

    Report Number
    1644487-2010-02638
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FAULTED SYSTEMS DIAGNOSTICS TEST OCCURRED DURING AN APPOINTMENT WHICH RESULTED IN DISABLING THE PATIENT'S GENERATOR. IT IS MOST LIKELY THAT THIS ISSUE OCCURRED AND WAS ADDRESSED IN THE SAME OFFICE APPOINTMENT; HOWEVER, A COPY OF THE FLASHCARD HAS NOT BEEN RECEIVED TO CONFIRM. (B)(4) ATTEMPTS TO OBTAIN A COPY OF THE FLASHCARD HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR