BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1030361 · Received April 16, 2008

    Report

    Report Number
    1644487-2008-00935
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    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

    REPORTER INDICATED THAT A VNS PATIENT'S OUTPUT CURRENT AND MAGNET OUTPUT CURRENT WERE SET TO 0MA. THE PATIENT REPORTED NOT BEING ABLE TO FEEL STIMULATION A SHORT TIME AFTER HER LAST PROGRAMMING SESSION. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1