BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1212569 · Received October 24, 2008

    Report

    Report Number
    1644487-2008-02588
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS THERAPY PATIENT BEGAN HAVING AN INCREASE IN SEIZURES 7 MONTHS POST LEAD REVISION SURGERY. THE INCREASE IN SEIZURES WAS ABOVE THE PATIENT'S PRE-VNS BASELINE. THE CHILD HAS TUBULAR SCLEROSIS AND THEY ARE NOT SURE IF THE EVENTS ARE RELATED TO DISEASE PROGRESSION OR BECAUSE OF THE VNS SETTINGS. DIAGNOSTIC TESTING IS WITHIN NORMAL LIMITS. THE PHYSICIAN INCREASED THE PATIENT'S DEVICE SETTINGS, AND ALSO CHANGED THE PATIENT'S MEDICATIONS. SINCE THE CHANGES THE PATIENT HAS DONE "MIRACULOUSLY BETTER" WITH SEIZURE CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 013476

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention