BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1638232 · Received March 16, 2010

    Report

    Report Number
    1644487-2010-00654
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    October 14, 2005
    Report Date
    February 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING MANUFACTURER REVIEW OF A PATIENT'S VNS PROGRAMMING HISTORY, IT WAS NOTED A PATIENT'S VNS OUTPUT CURRENT WAS LEFT AT 1MA ON THE DAY OF INITIAL IMPLANT SURGERY. AN INTERRUPTED SYSTEMS DIAGNOSTICS TEST CAUSED THE SETTINGS TO CHANGE. THIS WAS NOTED BY THE SURGEON, BUT ONLY THE MAGNET MODE CURRENT WAS PROGRAMMED BACK TO 0MA, WHILE THE OUTPUT CURRENT WAS LEFT AT 1MA. WHEN THE PATIENT WAS INITIALLY INTERROGATED AT THE NEUROLOGIST'S OFFICE TWO WEEKS LATER, THE VNS SETTINGS WERE ADJUSTED. FOLLOW UP WITH THE SURGEON REVEALED THE OUTPUT CURRENT WAS INTENDED TO BE LEFT AT 0MA, AND THAT THIS WAS AN OVERSIGHT THAT WAS NOT NOTED AT THE TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR