BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEEP BRAIN STIMULATION DEVICES

    MDR report key: 926830 · Received October 11, 2007

    Report

    Report Number
    2182207-2007-03183
    Event Type
    Other
    Date Received
    October 11, 2007
    Report Date
    September 30, 2005
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP IS IN PROCESS TO ESTABLISH SPECIFIC EVENTS DETAILS AND ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN AVAILABLE.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: BISEUL I, ET AL. "FEAR RECOGNITION IS IMPAIRED BY SUBTHALAMIC NUCLEUS STIMULATION IN PARKINSON'S DISEASE." NEUROPSYCHOLOGIA. 2005: 43(7): P1054-1059. THE ARTICLE DESCRIBES THE RESULTS OF A STUDY DESIGNED TO EVALUATE BEHAVIORAL CHANGES IN PARKINSONS DISEASE PATIENTS BEING TREATED WITH BILATERAL STN DBS THERAPY FOR SEVERE MOTOR FUNCTION AND/OR DYSKINESIAS SYMPTOMS. THE GROUP TREATED WITH DBS (N=15) DEMONSTRATED A SPECIFIC IMPAIRMENT TO RECOGNIZE FEAR FACIAL EXPRESSIONS. NO INDIVIDUAL PATIENT DATA WAS PROVIDED. ALL RESULTS WERE GROUP BASED. REPORTABLE EVENTS: 1. STIMULATOR (N=15), DBS LEADS (N=30) REDUCED ABILITY TO RECOGNIZE FEAR FACIAL EXPRESSIONS (PATIENTS N=15). THE STIMULATOR USED WAS NOT IDENTIFIED BY TYPE OR MANUFACTURER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR