BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNS THEREAPY PULSE

    MDR report key: 662931 · Received November 17, 2005

    Report

    Report Number
    1644487-2005-00795
    Event Type
    Malfunction
    Date Received
    November 17, 2005
    Date of Event
    October 18, 2005
    Report Date
    October 20, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT COULD NO LONGER FEEL STIMULATION AFTER LEAVING THE DR'S OFFICE. IT WAS FURTHER REPORTED THAT THE PT WAS SEEN APPROXIMATELY ONE WEEK LATER AND HIS PULSE GENERATOR WAS FOUND TO BE PROGRAMMED TO OMA OUTPUT CURRENT, WHICH WOULD RESULT IN NO STIMULATION. THE PT'S DEVICE WAS REPROGRAMMED TO THE DESIRED SETTINGS AND THE PT CAN NOW FEEL THE DEVICE STIMULATE. IT IS LIKELY THAT DURING THE PREVIOUS APPOINTMENT, AN INTERRUPTED LEAD TEST OCCURRED DURING DEVICE PROGRAMMING WHICH RESULTED IN A OMA OUTPUT CURRENT. CLINICIAN WAS ADVISED BY THE MFR, AS STATED IN THE LABELING, TO VERIFY THE DEVICE SETTING AS THE LAST STEP WHEN PROGRAMMING THE VNS SYSTEM. NO SERIOUS INJURIES WERE REPORTED. PT IMPLANTED FOR DEPRESSION INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THEREAPY PULSE PULSE GENERATOR (MUZ) MUZ CYBERONICS, INC. 102R 11003

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR