BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 954300 · Received November 27, 2007

    Report

    Report Number
    2182207-2007-04089
    Event Type
    Injury
    Date Received
    November 27, 2007
    Report Date
    October 17, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: LIM, ET AL. "ELECTRICAL STIMULATION OF THE ANTERIOR NUCLEUS OF THE THALAMUS FOR INTRACTABLE EPILEPSY: A LONG-TERM FOLLOW-UP STUDY." EPILEPSIA, 2007, 48:342-7. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: LIM, ET AL. "ELECTRICAL STIMULATION OF THE ANTERIOR NUCLEUS OF THE THALAMUS FOR INTRACTABLE EPILEPSY: A LONG-TERM FOLLOW-UP STUDY." EPILEPSIA, 2007, 48:342-7. FOUR PATIENTS UNDERWENT STEREOTACTIC IMPLANTATION OF QUADRIPOLAR STIMULATING ELECTRODES IN THE BILATERAL ANT, GUIDED BY SINGLE-UNIT MICROELECTRODE RECORDING. THE PATIENTS WERE FOLLOWED FOR A MEAN OF 44 MONTHS. REPORTABLE EVENT: A FEMALE PATIENT BEING TREATED WITH STN BILATERAL DEEP BRAIN STIMULATION FOR CPS AND GTCS (SEIZURE) HAD HER STIMULATOR ACCIDENTALLY TURNED OFF AT 7-12 MONTHS CAUSING INCREASED SEIZURE ACTIVITY. SEIZURE ACTIVITY DECREASED WHEN THE STIMULATOR WAS REACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention LEAD MODEL 3387 (N=2)