BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1760487 · Received July 15, 2010

    Report

    Report Number
    1644487-2010-01632
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED MULTIPLE SEIZURES AND HAD AN EPISODE OF STATUS AFTER WATCHING A 3D MOVIE. THE PT WAS TAKEN TO THE HOSPITAL AND WAS GIVEN ATIVAN. THE PT DID NOT RESPOND TO MAGNET SWIPES. THE PT WAS LATER SEEN BY A NEUROLOGIST WHO INCREASED THE PT'S DOSE OF LAMICTAL. THE PT HAS BEEN REFERRED FOR GENERATOR REVISION. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 016488

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention