BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 939951 · Received November 7, 2007

    Report

    Report Number
    2182207-2007-03715
    Event Type
    Injury
    Date Received
    November 7, 2007
    Report Date
    October 14, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: BALASH ET AL. "SUICIDAL THOUGHTS IN PATIENTS WITH PARKINSON'S DISEASE TREATED BY DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEI: TWO CASE REPORTS AND REVIEW OF THE LITERATURE" ACTA NEUROPSYCHIATRICA 2007:19:3: 208-210. [SEE SCANNED PAGES]

    Description of Event or Problem · 1

    JOURNAL REFERENCE: BALASH ET AL. "SUICIDAL THOUGHTS IN PATIENTS WITH PARKINSON'S DISEASE TREATED BY DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEI: TWO CASE REPORTS AND REVIEW OF THE LITERATURE" ACTA NEUROPSYCHIATRICA 2007:19:3: 208-210. TWO PATIENT WITH SERIOUS LIFE-THREATENING DEPRESSING EPISODES ARE DESCRIBED. A MALE PATIENT WITH A HISTORY PARKINSON'S DISEASE, DYSKINESIAS, FREEZING OF GAIL AND FESTINATIONS WAS SUCCESSFULLY TREATED WITH DBS. MOTOR SKILL IMPROVEMENT WAS OBSERVED. ABOUT TWO AND A HALF MONTHS POST-OP AND FOLLOWING A CHANGE IN THE LEFT SIDE STN ELECTRODE STIMULATION CONTACT POINT, THE PATIENT BEGAN TO EXPERIENCE DEPRESSION RELATED STIMULATION (ANXIETY, CONCENTRATION DIFFICULTY, INSOMNIA, COGNITIVE CHANGES) TO INCLUDE SUICIDAL THOUGHTS. ADJUSTMENT OF THE ELECTRODE CONTACT POINT BACK TO THE ORIGINAL SETTING RESOLVED THE DEPRESSION SYMPTOMS.

    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 51 YR Hospitalization| R