BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 6052852 · Received October 24, 2016

    Report

    Report Number
    3007566237-2016-03699
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    August 2, 2016
    Report Date
    October 24, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    FARRIS, S.M., GIROUX, M.L. RAPID ASSESSMENT OF GAIT AND SPEECH AFTER SUBTHALAMIC DEEP BRAIN STIMULATION. SURGICAL NEUROLOGY INTERNATIONAL. 2016. 7(SUPPL 19):S545-550. DOI: 10.4103/2152-7806.187532. SUMMARY: WE RETROSPECTIVELY REVIEWED 29 PATIENTS THAT HAD IMPROVEMENT IN GAIT AND/OR SPEECH WITHIN 30 MIN AFTER TURNING STIMULATION OFF. CLINICAL DATA ANALYZED INCLUDE UNIFIED PARKINSON'S DISEASE (PD) RATING SCALE MOTOR SCORES AND STIMULATION PARAMETERS BEFORE AND AFTER ADJUSTING STIMULATION. ALL PATIENTS RECEIVED ELECTRODE EFFICACY AND SIDE EFFECT THRESHOLD TESTING. STIMULATION PARAMETERS WERE ADJUSTED TO MAXIMIZE EFFICACY, AVOID SIDE EFFECTS, AND MAXIMIZE BATTERY LONGEVITY. REPORTED EVENTS: A PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) FOR IDIOPATHIC PARKINSON'S DISEASE (PD) EXPERIENCED STIMULATION INDUCED SPEECH AND GAIT DEFICITS WHICH IMPROVED WITHIN 30 MINUTES OF TURNING OFF STIMULATION. THE AUTHORS REPORTED THAT THIS PATIENT REQUIRED A LEAD REVISION DUE TO UNAVOIDABLE STIMULATION SIDE EFFECTS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701940 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention