BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1120744 · Received August 15, 2008

    Report

    Report Number
    1644487-2008-01924
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 17, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. ONE OF THE ELECTRODES DID NOT APPEAR TO BE FULLY WRAPPED AROUND THE NERVE. ONE OF THE THREE TIE-DOWNS WAS NOT ATTACHED TO THE LEAD BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT EXPERIENCED A FALL, AND HAD APPROX 14 SEIZURES THE WEEKEND PRIOR TO HIS ROUTINE OFFICE VISIT. HE WAS TAKEN TO THE ER WHERE HE WAS TREATED AND THEN RELEASED. AT THE NEUROLOGIST'S OFFICE A FEW DAYS LATER, THE PT EXPERIENCED SEIZURES AND PAINFUL STIMULATION DURING DIAGNOSTIC TESTING. THE VNS DEVICE WAS PROGRAMMED OFF, AND THEN THE PT WENT INTO STATUS EPILEPTICUS. THE PT WAS TAKEN TO ICU AT THE HOSPITAL. THE PT WAS TREATED FOR TOXIC AED LEVELS. THE PT HAS BEEN DISCHARGED FROM THE HOSPITAL. DIAGNOSTIC TESTING SHOWED THE VNS DEVICE TO BE FUNCTIONING PROPERLY. X-RAYS WERE SENT TO THE MANUFACTURER FOR REVIEW. A REVIEW OF THE X-RAYS REVEALED THAT ONE OF THE ELECTRODES DOES NOT APPEAR TO BE COMPLETELY WRAPPED AROUND THE NERVE. ADDITIONALLY, ONE OF THE THREE TIE-DOWNS PRESENT WAS NOT ATTACHED TO THE LEAD. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE. REVISION SURGERY IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization