BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRGRAMMING SOFTWARE

    MDR report key: 1080594 · Received July 22, 2008

    Report

    Report Number
    1644487-2008-01598
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VNS PROGRAMMING SOFTWARE WAS REPORTED TO HAVE RANDOMLY CHANGED VNS GENERATOR SETTINGS AFTER THE REPORTER HAD ENTERED NEW THERAPY PARAMETERS. THE PRODUCT WAS RETURNED TO THE MFR AND IS AWAITING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521404

    Patients

    Seq Age Sex Outcome Treatment
    1