BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1905609 · Received November 19, 2010

    Report

    Report Number
    1644487-2010-02632
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 22, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT IS HAVING AN INCREASE IN SEIZURES ABOVE PRE-VNS BASELINE LEVELS. THERE WAS NO KNOWN RELATION TO THE VNS THERAPY, BUT IN RESPONSE TO THE INCREASE IN SEIZURES, THE PT'S SETTINGS HAVE BEEN ADJUSTED FOR LOWER DUTY CYCLE AND PULSEWIDTH. THERE HAVE BEEN NO KNOWN CHANGES IN MEDICATIONS OR LIFESTYLE. THE PT HAS ALSO BEEN FOR GENERATOR REVISION, BUT THE EXPLANTED GENERATOR HAS YET TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200778

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention