BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1161208 · Received September 15, 2008

    Report

    Report Number
    2182207-2008-05762
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    August 20, 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: DRAPIER D, PERON J, LERAY E, ET AL. EMOTION RECOGNITION IMPAIRMENT AND APATHY AFTER SUBTHALAMIC NUCLEUS STIMULATION IN PARKINSON'S DISEASE HAVE SEPARATE NEURAL SUBSTRATES. NEUROPSYCHOLOGIA. 2008;46(11):2796-2801. THE OBJECTIVE OF THE STUDY WAS TO TEST THE HYPOTHESIS THAT EMOTION RECOGNITION AND APATHY SHARE THE SAME FUNCTIONAL CIRCUIT INVOLVING THE SUBTHALAMIC NUCLEUS (STN). A CONSECUTIVE SERIES OF 17 PTS WITH ADVANCED PARKINSON'S DISEASE (PD) WAS ASSESSED 3 MONTHS BEFORE AND 3 MONTHS AFTER STN DEEP BRAIN STIMULATION (DBS). REPORTABLE EVENT: A SIGNIFICANT REDUCTION IN CATEGORICAL FLUENCY AND PHONEMIC VERBAL FLUENCY WERE SEEN. SEE MFG REPORT 2182207200805759.

    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 UNK N=2| EXTENSION MODEL UNK N=2| PROGRAMMER MODEL UNK N=1