BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2391314 · Received December 21, 2011

    Report

    Report Number
    1644487-2011-03179
    Event Type
    Injury
    Date Received
    December 21, 2011
    Date of Event
    December 6, 2011
    Report Date
    December 7, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S CAREGIVER THAT THE PT HAS BEEN HAVING SEIZURES, ABOUT BASELINE OR A LITTLE FEWER. HOWEVER, SOME OF THE SEIZURES ARE MORE INTENSE AND RESULT IN THE PT FALLING OUT OF THE CHAIR. THE NEUROLOGIST REPORTEDLY ATTEMPTED TO TURN THE MAGNET MODE UP ON (B)(6) 2011 WHICH CAUSED SEVERE CHOKING AND COUGHING. HE THEN TURNED HIS MAGNET MODE DOWN, BUT THE PT WAS STILL HAVING PAINFUL STIMULATION. PT HAS MULTIPLE CO-MORBITIES HAS PSEUDO-SEIZURES. HOWEVER, THE PT'S NEUROLOGIST FEELS THAT HE SEES AN AREA OF SEIZURE ACTIVITY PER EEG. ATTEMPTS FOR ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200629

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other