BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL STRIP ELECTRODE

    MDR report key: 518728 · Received April 1, 2004

    Report

    Report Number
    9612007-2004-00026
    Event Type
    Injury
    Date Received
    April 1, 2004
    Report Date
    April 1, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    GYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NEUROSURGEON REPORTS USING THE 16223-3J AND THE 16223-3 MODEL ELECTRODE STRIPS. THE SURGEON REPORTS USING THIS TYPE OF MONITORING/IMPLANTING TECHNIQUE FOR OVER TEN YEARS. THE ELECTRODE STRIPS ARE USED FOR MONITORING PURPOSES ONLY AND ARE NOT TO BE IMPLANTED. THE SURGEON PLACES SIX TO EIGHT STRIPS AT A TIME THROUGH ONE BURR HOLE. THE PT RECEIVES AT LEAST THREE BURR HOLES. UPON REMOVAL OF THE ELECTRODE STRIPS APPROX 2.5 WEEKS LATER SOME OF THE ELECTRODE STRIPS (TWO OR THREE) BROKE OFF AT THE THIRD CONTACT. THE PT REQUIRED CRANIECTOMY TO RETRIEVE THE BROKEN STRIPS. THIS NEUROSURGEON HAD PREVIOUSLY USED ANOTHER COMPETITOR'S (ADTECH) ELECTRODE STRIPS WITH THE SAME TYPE OF INCIDENT AS DESCRIBED ABOVE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. ADD'L INFO WAS RECEIVED FROM THE SURGEON. THE SURGEON INDICATED HE USED A SMALLER INSERTION TOOL TO IMPLANT THE DEVICES, THEREFORE HE FEELS THE SMALLER TOOL, LEFT SMALLER HOLES AND HAD FEWER CEREBROSPINAL FLUID LEAKS BUT ALSO MADE IT MUCH HARDER TO REMOVE THE ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL STRIP ELECTRODE EPILEPSY PRODUCT GYC INTEGRA NEUROSCIENCES IMPLANTS S.A. * VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention