BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNS THERAPY PULSE

    MDR report key: 623156 · Received July 25, 2005

    Report

    Report Number
    1644487-2005-00488
    Event Type
    Malfunction
    Date Received
    July 25, 2005
    Date of Event
    June 24, 2005
    Report Date
    June 28, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICES OUTPUT CURRENT WAS FOUND TO SET TO OMA. NO ADVERSE EVENTS WERE REPORTED. IT IS LIKELY THAT DURING THE PATIENT'S LAST APPOINTMENT, THERE WAS AN INTERRUPTED LEAD TEST, LEAVING THE DEVICE'S OUTPUT CURRENT AT OMA. HOWEVER, THE MANUFACTURER HAS NOT RECEIVED THE PROGRAMMING HISTORY TO VERIFY THE CAUSE OF THE EVENT. THE EVENT IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT NEUROLOGIST INDICATED THAT HE NEVER INTERROGATES THE DEVICE AFTER AS THE LAST STEP OF ANY PROGRAMMING SESSION TO VERIFY CORRECT SETTINGS FOR EACH PARAMETER. NEUROLOGIST HAS SINCE BEEN ADVISED ON THE IMPORTANCE OF THIS. IT WAS REPORTED THAT THE PT'S DEVICE WAS REPROGRAMMED TO PRESCRIBED SETTINGS AND THAT THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102-02 11608

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR