BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2022967 · Received February 24, 2011

    Report

    Report Number
    1644487-2011-00342
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT CAME INTO A ROUTINE OFFICE VISIT AND COULD NO LONGER FEEL STIMULATION AFTER BEING SCANNED BY A SECURITY WAND. UPON INTERROGATION, IT WAS FOUND THAT THE VNS OUTPUT CURRENT AND MAGNET CURRENT HAD BEEN SET TO 0MA. FURTHER PROGRAMMING HISTORY IS BEING REQUESTED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE LOSS OF THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 678294

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR