BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1241168 · Received November 20, 2008

    Report

    Report Number
    1644487-2008-02789
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 31, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VNS PATIENT'S CAREGIVER THAT ONCE THE DEVICE WAS TURNED ON, THE PATIENT HAD A GRAND MAL SEIZURE AND WAS TAKEN TO THE EMERGENCY ROOM. THE PATIENT HAS NOT HAD THIS TYPE OF SEIZURE IN SEVERAL YEARS. THE PATIENT'S DEVICE WAS TURNED OFF BY HER TREATING PHYSICIAN. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THE PATIENT'S EVENT HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200759

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention