BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 939950 · Received November 7, 2007

    Report

    Report Number
    2182207-2007-03716
    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.

    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 PATIENTS WITH SERIOUS LIFE-THREATENING DEPRESSIVE EPISODES ARE DESCRIBED. A FEMALE PATIENT WITH A HISTORY OF PARKINSON'S DISEASE, TREMOR, RIGIDITY, DYSKINESIAS, AKINESIA AND LEG DYSTONIA WAS SUCCESSFULLY TREATED WITH DBS. SIGNIFICANT MOTOR SKILL IMPROVEMENT WAS OBSERVED. SOME DYSPHASIC DYSKINESIA WAS NOTED TWO MONTHS POST-OP THOUGHT TO BE RELATED TO OVERSTIMULATION OF THE LEFT STN ELECTRODE. NON-INVASIVE ADJUSTMENTS (DECREASE) OF THE STIMULATION LEVEL CORRECTED THE DYSKINESIA. FOLLOWING THE ADJUSTMENT THE PATIENT'S DYSKINESIA WAS IMPROVED BUT WITHIN 24 HOURS SHE EXPERIENCED SEVERE AND PERSISTENT DEPRESSION SYMPTOMS WITH SUICIDAL THOUGHTS. SHE WAS HOSPITALIZED IN THE PSYCHIATRIC CLINIC AND TREATED WITH FLUOXETINE AND VENLAFAXINE. RESTARTING LEVODOPA (500 MG/DAY) RESOLVED THE DEPRESSION SYMPTOMS IN A FEW HOURS. FOLLOW-UP AT ONE YEAR FOUND THE PATIENT ON A SMALL DOSAGE OF LEVODOPA WITH NO 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 48 YR Hospitalization| R