BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1071636 · Received July 9, 2008

    Report

    Report Number
    1644487-2008-01571
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    May 1, 2007
    Report Date
    June 30, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT EXPERIENCED AN INCREASE IN SEIZURES ABOVE PREVIOUS BASELINE. THE PHYSICIAN ALSO INDICATED THE SEIZURES WERE MORE SEVERE. THE PT'S VNS DEVICE WAS PROGRAMMED OFF, AND THE SEIZURES DECREASED AND WERE LESS SEVERE. DEVICE DIAGNOSTICS SHOWED VNS TO BE FUNCTIONING PROPERLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention