BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1159087 · Received September 12, 2008

    Report

    Report Number
    2182207-2008-05649
    Event Type
    Injury
    Date Received
    September 12, 2008
    Report Date
    August 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: LE JEUNE F, PERON J, BISEUL I, ET AL. SUBTHALAMIC NUCLEUS STIMULATION AFFECTS ORBITOFRONTAL CORTEX IN FACIAL EMOTION RECOGNITION: A PET STUDY. BRAIN. 2008; 131 (PT.6): 1599-1608. THE OBJECTIVE OF THE PRESENT STUDY WAS FIRST, TO REINFORCE OUR PREVIOUS RESULTS BY DEMONSTRATING REDUCED FEAR RECOGNITION IN OUR PARKINSON'S DISEASE PT GROUP FOLLOWING STN DBS AND, SECOND, TO CORRELATE THESE EMOTIONAL PERFORMANCES WITH GLUCOSE METABOLISM USING FDG-PET. THE FDG-PET AND RFE, RECOGNITION OF FACIAL EMOTIONS, TASKS WERE BOTH PERFORMED BY A COHORT OF 13 PARKINSON'S DISEASE PTS 3 MOS BEFORE AND 3 MOS AFTER SURGERY FOR STN DBS. AS PREDICTED, WE OBSERVED A SIGNIFICANT REDUCTION IN FEAR RECOGNITION FOLLOWING SURGERY AND OBTAINED A POSITIVE CORRELATION BETWEEN THESE NEUROPSYCHOLOGICAL RESULTS AND CHANGES IN GLUCOSE METABOLISM, ESPECIALLY IN THE RIGHT OFC, ORBITOFRONTAL CORTEX. REPORTABLE EVENT: TOTAL RFE, RECOGNITION OF FACIAL EMOTION, WAS SIGNIFICANTLY IMPAIRED FOLLOWING STN DBS, COMPARED WITH THE PREOPERATIVE ASSESSMENT. THIS WAS MAINLY DUE TO THE FEAR EMOTION. SEE MFG REPORT 2182207200805650.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LEAD MODEL 3389 N=2| EXTENSION MODEL UNK N=2| PROGRAMMER MODEL UNK N=1