BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1008135 · Received March 6, 2008

    Report

    Report Number
    2182207-2008-01106
    Event Type
    Injury
    Date Received
    March 6, 2008
    Report Date
    February 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: TSAI ST, LIN SH, LIN SZ, CHEN JY, LEE CW, CHEN SY. NEUROPSYCHOLOGICAL EFFECTS AFTER CHRONIC SUBTHALAMIC STIMULATION AND THE TOPOGRAPHY OF THE NUCLEUS IN PARKINSONS DISEASE. NEUROSURGERY 2007; 61 (5): E1024-E1030.

    Description of Event or Problem · 1

    TSAI ST, LIN SH, LIN SZ, CHEN JY, LEE CW, CHEN SY. NEUROPSYCHOLOGICAL EFFECTS AFTER CHRONIC SUBTHALAMIC STIMULATION AND THE TOPOGRAPHY OF THE NUCLEUS IN PARKINSONS DISEASE. NEUROSURGERY 2007; 61 (5): E1024-E1030. THE ARTICLE DESCRIBES THE RESULTS OF A RETROSPECTIVE STUDY OF 38 PARKINSONIAN PTS WHO UNDERWENT BILATERAL STN-DBS. THE AIM OF THE STUDY WAS TO TRY TO ADDRESS THE CORRELATION BETWEEN THE ELECTRODE LOCATION WITHIN THE STN AND THE DEVELOPMENT OF POSTOPERATIVE NEUROPSYCHOLOGICAL EVENTS AFTER CHRONIC STIMULATION. EIGHT PTS EXPERIENCED NEUROPSYCHOLOGICAL SIDE EFFECTS. FOUR PTS (LEAD N=4) EXPERIENCED A COMBINATION OF 7 NEUROPSYCHOLOGICAL SIDE EFFECTS THAT INCLUDED (DEPRESSION IN 2 PTS, HYPOMANIA/MANIA 2 PTS, PSYCHOSIS IN 1 PT AND IMPULSE CONTROL PROBLEMS IN 2 PTS). SOME PTS EXPERIENCED MORE THAN ONE SIDE EFFECT. TREATMENT AND OUTCOME INFO WAS NOT PROVIDED. NOTE: FROM THE DATA PRESENTED IN THE ARTICLE, IT WAS NOT POSSIBLE TO DETERMINE WHICH SIDE EFFECTS WERE LINKED WITH EACH OF THE 4 PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3387 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other LEAD MODEL 3387 (N=1)| IPG MODEL 7428 (N=1)| LEAD EXT (N=2)