BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 954301 · Received November 27, 2007

    Report

    Report Number
    2182207-2007-04087
    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

    YES. JOURNAL REFERENCE: LIM, ET AL. "ELECTRICAL STIMULATION OF THE ANTERIOR NUCLEUS OF THE THAMALUS 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 MALE PATIENT BEING TREATED WITH BOTH ANT AND STN BILATERAL DEEP BRAIN STIMULATION FOR GTCS (SEIZURE) EXPERIENCED STIMULATION INDUCED SEIZURES (4) WHEN STN STIMULATION WAS ON. THE STN ELECTRODES (DBS LEADS 3387 N=2) WERE REMOVED AND THE PATIENT NOTED MILD LEFT-HAND WEAKNESS 2 DAYS AFTER REMOVAL OF THE STN ELECTRODES. BRAIN MRI REVEALED A SMALL RIGHT FRONTAL HEMORRHAGE. THE WEAKNESS WAS TRANSIENT WITH NO PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3387 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R LEAD MODEL 3387 (2)