BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1931692 · Received November 22, 2010

    Report

    Report Number
    1644487-2010-02641
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 25, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PT'S MOTHER THAT SINCE IMPLANT, HIS SEIZURE INTENSITY HAS DECREASED DRASTICALLY SINCE IMPLANT. SHE IS VERY HAPPY WITH VNS SO FAR, BUT PRIOR TO VNS HE WAS HAVING CLUSTER SEIZURES (2-3 A DAY) EVERY 2-3 WEEKS. SINCE IMPLANT HE IS HAVING 2-3 DAYS OF CLUSTER SEIZURES A WEEK, BUT SHE AGAIN SAID THEY ARE MUCH LESS SEVERE AND THE STIMULATION SEEMS TO BRING HIM OUT OF THE SEIZURES. SHE DENIES THEY TRAUMA OR MEDICATION CHANGES. THE PT HAS ONLY HAD 4 PROGRAMMING SESSIONS SINCE IMPLANT. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL 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 2495

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR