BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1120812 · Received August 15, 2008

    Report

    Report Number
    1644487-2008-01931
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT IS EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY. THE PATIENT'S SEIZURE ACTIVITY LEVEL PRIOR TO VNS IS UNKNOWN. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 3536

    Patients

    Seq Age Sex Outcome Treatment
    1 Other