BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 5567659 · Received April 11, 2016

    Report

    Report Number
    3007566237-2016-01634
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    January 1, 2007
    Report Date
    April 11, 2016
    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

    EVENT DATE: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE YEAR OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BALASH, Y., MERIMS, D., GILADI, N. 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). DOI:208-210.10.1111/J.1601-5 215.2007.00177.X. SUMMARY: DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEI (STN) CAN RESULT IN DEPRESSION DESPITE THE OBVIOUS MOTOR IMPROVEMENT. DBS-INDUCED DEPRESSION POSSIBLY HAS PATHOGENETIC DIFFERENCES FROM ORDINARY PARKINSON'S DISEASE DEPRESSION. THE STN REGION SEEMS TO BE A SENSITIVE ZONE THAT INFLUENCES EMOTIONS. REPORTED EVENTS: PATIENT 2: A (B)(4) WOMAN WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) FOR PARKINSON'S DISEASE (PD) EXPERIENCED A "DRAMATIC" IMPROVEMENT IN HER PHYSICAL STATE. LEVODOPA THERAPY WAS DISCONTINUED BECAUSE OF THE ENHANCEMENT OF DYSKINESIAS, WHILE A RELATIVELY WEAK DOSE OF ROPINIROLE (2-4 MG/DAY) WAS GIVEN AS THE ONLY DOPAMINERGIC TREATMENT. TWO MONTHS POSTOPERATIVELY, THE PATIENT DEVELOPED DIPHASIC DYSKINESIAS (ALSO KNOWN AS ONSET AND END OF DOSE DYSKINESIA') IN HER RIGHT EXTREMITIES, PROBABLY BECAUSE OF OVERSTIMULATION OF THE LEFT STN. AS A RESULT, THE VOLTAGE OF STN STIMULATION WAS DECREASED AND THE ADMINISTRATION OF ROPINIROLE WAS STOPPED. IT WAS NOTED THAT PRIOR TO SURGERY THE PATIENT'S AFFECTIVE AND COGNITIVE STATES WERE NORMAL, AND THEY HAD NO HISTORY OF DEPRESSION OR OTHER PSYCHIATRIC DISORDER; HOWEVER, TWENTY-FOUR HOURS AFTER THESE CHANGES TO DBS VOLTAGE AND MEDICATION DOSAGE THE DYSKINESIAS GREATLY IMPROVED, BUT HER MOOD HAD ABRUPTLY AND SEVERELY WORSENED DUE TO THE APPEARANCE OF SEVERE AND PERSISTENT DEPRESSION. SHE FELT EXTREME DESPAIR, HAD GENERAL RESTLESSNESS, HAD INSOMNIA WITH HORRORS TO LIVE ONE MORE DAY AND HAD APATHY WITH A NEED FOR MUCH ENERGY TO MAKE USUAL DAILY ACTIVITIES. SHE COULD NOT COOPERATE IN ANY PSYCHOLOGICAL TREATMENT, BEING CONVINCED THAT SHE CANNOT BE HELPED. SUICIDE IDEATIONS WERE STRONG UP TO PREPARING FAREWELL LETTER AND ACTIVE SEARCHING FOR GUN. BECAUSE OF SEVERE DEPRESSION AND PLANNING SUICIDE, THE PATIENT WAS HOSPITALIZED AT (B)(6) CLINIC AND TREATED BY FLUOXETINE AND VENLAFAXINE. ROPINIROLE WAS RESTARTED WITH MODEST ANTIDEPRESSIVE EFFECT. HOWEVER, RESTARTING LEVODOPA AT A DOSE OF 500 MG/DAY HAD CUT OFF ALL DEPRESSION SYMPTOMS IN 4-6 H. HER MOTOR CONDITION REMAINED GOOD, WITH VERY MILD DYSKINESIAS IN THE RIGHT EXTREMITIES. ONE-YEAR FOLLOW-UP AND ON SMALL DOSE OF LEVODOPA DID NOT SHOW SIGNS OF DEPRESSION. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. FOLLOW-UP TO THE ARTICLE'S CORRESPONDING AUTHOR HAS BEEN REQUESTED FOR ADDITIONAL/MISSING EVENT INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222281 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| L