BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 2000313 · Received February 18, 2011

    Report

    Report Number
    1644487-2011-00315
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    July 19, 2010
    Report Date
    January 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN EPILEPTOLOGIST THAT A VNS PT EXPERIENCED INTERMITTENT PAIN IN THE CHEST GENERATOR AREA AND ELECTRODE SITE DUE TO UNK REASON. THE EPILEPTOLOGIST INDICATED THE PAIN WAS NOT ALWAYS ASSOCIATED WITH STIMULATION AND CURRENT DIAGNOSTICS WERE WITHIN NORMAL LIMITS (NO SPECIFICS). THE EPILEPTOLOGIST REDUCED THE PT'S SETTINGS FROM 1.75 MA TO 1MA, IN TURN THIS REDUCED THE PT'S PAIN. MOREOVER, F/U FROM A COMPANY REP WITH THE EPILEPTOLOGIST REVEALED THE PT IS DOING WELL AND WAS NOT COMPLAINING OF PAIN OR ANY MIGRATION. THE EPILEPTOLOGIST DOES NOT BELIEVE THE PT'S DEVICE MIGRATED AS THERE MIGHT HAVE BEEN A COMPLAINT FROM THE PT REGARDING THE EVENT. ADDITIONAL INFORMATION WAS REC'D FROM A COMPANY REP INDICATING THE PT CONTINUED TO HAVE PAINFUL STIMULATION AT THE NECK SITE AND NOW FELT LIKE THERE WAS A KNOT THERE. THE PT'S EPILEPTOLOGIST WAS NOW REFERRING THE PT TO THE SURGEON FOR POSSIBLE FULL REVISION. AT THE MOMENT, IT IS UNK IF MEDICAL INTERVENTION IS BEING TAKEN FOR THE REPORTED PAINFUL STIMULATION AS GOOD FAITH ATTEMPTS TO THE TREATING EPILEPTOLOGIST HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention