BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1919082 · Received November 23, 2010

    Report

    Report Number
    1644487-2010-02657
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS SUSPECTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT WAS FEELING THE STIMULATION INTERMITTENTLY. THE PHYSICIAN INDICATED THAT PT UNDERWENT EEG TESTING, DURING WHICH THEY COULD ALWAYS IDENTIFY WHEN THE VNS WAS FIRING DUE TO THE SIGNALS IT PRODUCED; HOWEVER, OVER THE 3-DAY TEST PERIOD, THE PHYSICIAN SAID, THE VNS DID NOT APPEAR TO GO OFF AT ALL. WHEN THE PT'S MAGNET MODE SETTINGS WERE INITIALLY INCREASED, THE PT WAS ABLE TO FEEL THE STIMULATION, BUT WHEN THE NORMAL MODE OUTPUT CURRENT WAS INCREASED AND WATCHED FOR 20-30 MINUTES, THE PT WAS NOT FEELING STIMULATION OR COUGHING LIKE SHE WOULD PREVIOUSLY. THE DIAGNOSTICS WERE PERFORMED AT THAT TIME, THEY RESULTED WITHIN NORMAL LIMITS, BUT WHEN PERFORMED AGAIN, A DROP IN DCDC-VALUE WAS OBSERVED. THE PT WAS SAID TO BE HAVING AN INCREASE IN SEIZURES. THE PT WAS REFERRED FOR X-RAYS, BUT THEY HAVE NOT BEEN SENT TO THE MFR FOR REVIEW AS THEY ARE CURRENTLY WITH THE PT. THERE WERE NO REPORTS OF TRAUMA OR MANIPULATION NOR WERE THERE ANY CAUSAL OR CONTRIBUTORY FACTORS, PRECEDING THE ONSET OF ANY OF THE REPORTED EVENTS. THE RELATIONSHIP OF THE INCREASE IN SEIZURES TO BASELINE LEVELS IS UNK. THE PT DID HAVE A SIGNIFICANT IMPROVEMENT IN SEIZURE CONTROL ONCE IMPLANTED WITH VNS; HOWEVER RECENTLY, THE SEIZURES HAVE INCREASED. THE CAUSE FOR THE INCREASE IS BELIEVED TO POSSIBLY BE RELATED TO THE RECENT CHANGE IN DCDC-VALUE. THE PT IS EXPECTED TO BE REFERRED FOR LEAD REVISION. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200845

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR