BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 982559 · Received January 18, 2008

    Report

    Report Number
    2182207-2008-00337
    Event Type
    Injury
    Date Received
    January 18, 2008
    Report Date
    January 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GEDAY CE, KONRAD PE, GJEDDE A. STIMULATION OF SUBTHALAMIC NUCLEUS INHIBITS EMOTIONAL ACTIVATION OF FUSIFORM GYRUS. NEUROIMAGE. 2006; 32(2): 706-714. THE ARTICLES DESCRIBES A STUDY INVOLVING 9 PATIENTS BEING TREATED WITH DEEP BRAIN STIMULATION (DBS) FOR SYMPTOMS RELATED TO PARKINSONS DISEASE. THE STUDY DEMONSTRATED THAT THE 9 PATIENTS HAVE IMPAIRED PRIMARY FACE RECOGNITION AND DIMINISHED ABILITY TO RECOGNIZE EMOTIONS EXPRESSED IN FACES WITH THE STIMULATOR ON. THE AIM OF THE ARTICLE WAS TO DETERMINE THE FACTORS RESPONSIBLE FOR THE IMPAIRMENT. REPORTABLE EVENT: A MALE PATIENT (6) EXPERIENCED IMPAIRED PRIMARY FACE RECOGNITION AND DIMINISHED ABILITY TO RECOGNIZE EMOTIONS EXPRESSED IN FACES. NO TREATMENT OR OUTCOME INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other IPG DUAL OUTPUT (N=1)| IPG SINGLE OUTPUT (N=2)| DBS LEAD UNK (N=1)| LEAD EXTENSION UNK (N=2)