BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1257433 · Received December 4, 2008

    Report

    Report Number
    1644487-2008-02920
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    January 1, 2008
    Report Date
    November 4, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT HAD BEEN SEEN LAST IN MAY AND HER OUTPUT CURRENT WAS 1.25 MA. WHEN SHE WAS SEEN IN NOVEMBER, HER OUTPUT CURRENT WAS SET TO 0 MA. HE DENIES CHANGING HER SETTINGS AND THE PATIENT DENIES SEEING ANY OTHER PHYSICIANS. PATIENT STATES THAT SHE STOPPED FEELING MAGNET STIMULATION AND NORMAL STIMULATION SEVERAL WEEKS PRIOR TO PHYSICIAN APPOINTMENT. THE CAUSE FOR THIS RESET EVENT IS UNKNOWN AT THIS TIME. ALL ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521393

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR