BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1008138 · Received March 6, 2008

    Report

    Report Number
    2182207-2008-01103
    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. A MAN BEING TREATED WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR SYMPTOMS RELATED TO PARKINSONS DISEASE DEVELOPED A MANIC EPISODE 3 MONTHS POST SURGERY, WHICH WAS CHARACTERIZED BY IRREGULAR SOCIAL ACTIVITIES, POOR RELATIONSHIPS WITH FAMILY, IRRITABLE MOOD, DECREASED NEED FOR SLEEP, INFLATED SENSE OF SELF-IMPORTANCE, RACING THOUGHTS AND INCREASED GOAL-DIRECTED ACTIVITY. POST OPERATIVE MRI SHOWED THAT THE ACTIVE CONTACT OF THE LEFT ELECTRODE MIGHT BE LOCATED AT OR NEAR THE ANTERIOR VENTRAL-MEDIAL TIP OF THE STN. THE MANIA SUBSIDED AFTER A PARAMETRIC ADJUSTMENT IN THE STIMULATION LEVEL. IN ADDITION, THE PT'S LEVODOPA WAS DECREASED BY 33%.

    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 50 YR Other 3387 (N=1)| 7428 (N=1)| PROGRAMMER| LEAD EXT (N=2)