BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 976558 · Received January 8, 2008

    Report

    Report Number
    2182207-2008-00068
    Event Type
    Injury
    Date Received
    January 8, 2008
    Report Date
    November 2, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: BRODSKY ET AL. "OFF -OFF REBOUND DYSKINESIA IN SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION OF PARKINSON'S DISEASE" MOVEMENT DISORDERS/2006//21/9/1487-1490.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: BRODSKY ET AL. "OFF -OFF REBOUND DYSKINESIA IN SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION OF PARKINSON'S DISEASE" MOVEMENT DISORDERS/2006//21/9/1487-1490. THE ARTICLE DESCRIBES A CASE STUDY OF A MALE PT THAT RECEIVED BILATERAL IMPLANTATION OF DBS IN THE STN FOR PARKINSON'S DISEASE. THEY REPORT A UNIQUE PATTERN (THREE SEPARATE EVALUATIONS IN A 2YEAR PERIOD) OF SELF-LIMITING DYSKINESIA THAT OCCURRED IN THE OFF MEDICATION STATE WHEN DBS WAS TURNED OFF. WHEN ELECTRODES WERE CONTINUOUSLY ON, AND OFF MEDICATION, HE WAS STILL SLIGHTLY DYSKINETIC. STIMULATION OF THE ELECTRODE AT THE SUPERIOR CONTACT IN COMBINATION WITH A SLIGHT REDUCTION OF L-DOPA DOSE, RESULTED IN SUPPRESSION OF DYSKINESIA. WHEN THE ELECTRODE WAS SWITCHED OFF DYSKINESIA APPEARED AND LASTED 2 HOURS, DESPITE THE PT BEING OFF ALL MEDICATIONS OVERNIGHT.

    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 61 YR Required Intervention EXTENSIONS| IMPLANTED STIMULATOR