BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNS THERAPY PULSE

    MDR report key: 648661 · Received December 2, 2005

    Report

    Report Number
    1644487-2005-00840
    Event Type
    Malfunction
    Date Received
    December 2, 2005
    Date of Event
    November 4, 2005
    Report Date
    November 4, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NEUROLOGIST'S PROGRAMMING SYSTEM WAS RETURNED TO MFR FOR ANALYSIS. ANALYSIS OF THE PROGRAMMING SYSTEM DID NOT IDENTIFY ANY DISCONTINUITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    DEVICE WAS INADVERTENTLY PROGRAMMED TO 8.0MA OUTPUT CURRENT DURING FIRST PROGRAMMING SESSION TO INITIATE STIMULATION FOLLOWING INITIAL IMPLANT SURGERY. IT WAS REPORTED THAT DEVICE INTERROGATION AT THE BEGINNING OF THE PROGRAMMING SESSION REVEALED THAT THE OUTPUT CURRENT WAS PROGRAMMED TO 0MA OUTPUT CURRENT AS EXPECTED BECAUSE STIMULATION WAS NOT INITIATED AT THE TIME OF IMPLANT APPROXIMATELY THREE WEEKS PRIOR. THE NEUROLOGIST THEN ATTEMPTED TO INCREASE OUTPUT CURRENT 0.25MA, BUT BEFORE THE DEVICE FINISHED THE SEQUENCE, A WARNING MESSAGE STATING THAT THE PROGRAMMING EVENT WAS NOT COMPLETED APPEARED ON THE COMPUTER SCREEN. AT THAT TIME, THE PATIENT STARTED SCREAMING AND CRYING, PLEADING FOR THE DEVICE TO BE TURNED OFF. WHEN THE WARNING MESSAGE WAS CLEARED, 8.0MA WAS BEING REPORTED FOR THE NORMAL MODE OUTPUT CURRENT. DEVICE INTERROGATION REPORTEDLY REVEALED THAT THE PATIENT'S DEVICE WAS IN FACT PROGRAMMED TO 8.0MA OUTPUT CURRENT. ONCE THE PATIENT DID NOT CALMED DOWN, THE NEUROLOGIST RE-INTERROGATED THE DEVICE AND SAW THAT THE OUTPUT CURRENT WAS AT 0MA. THE DEVICE WAS THEN PROGRAMMED TO 0.25MA OUTPUT CURRENT AND A FINAL ITERROGATION WAS PERFORMED TO CONFIRM THIS SETTING. THE PATIENT DID NOT FEEL STIMULATION AT THIS LEVEL. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT IS IN GOOD CONDITION AND WILL CONTINUE WITH THE VNS THERAPY WITH INCREMENTAL INCREASES IN DEVICE SETTINGS. NEUROLOGIST PLANS TO REPLACE HIS PROGRAMMING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR (LYJ) LYJ CYBERONICS, INC. 102 12704

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR