BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1161207 · Received September 15, 2008

    Report

    Report Number
    2182207-2008-05759
    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: APATHY WAS SIGNIFICANTLY WORSE AT M3 AFTER STN-DBS, IN RELATION TO THE PREOPERATIVE. THE ENTIRE POSTOPERATIVE GROUP WAS DEEMED TO BE SUFFERING FROM APATHY. THE COGNITIVE AND EMOTIONAL SUBSCORES OF THE APATHY SCALE WERE SIGNIFICANTLY LOWER AFTER SURGERY.

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