BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2553794 · Received April 30, 2012

    Report

    Report Number
    3007566237-2012-00932
    Event Type
    Injury
    Date Received
    April 30, 2012
    Date of Event
    June 30, 2011
    Report Date
    April 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_INS_STIMULATOR: LOT# , SERIAL# UNKNOWN, IMPLANTED:, EXPLANTED: PRODUCT TYP IMPLANTABLE NEUROSTIMULATOR. (B)(4). THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: THEVATHASAN, W., COYNE, T., HYAM, J., KERR, G., JENKINSON, N., AZIZ, T., SILBURN, P. PEDUNCULOPONTINE NUCLEUS STIMULATION IMPROVES GAIT FREEZING IN PARKINSON DISEASE. NEUROSURGERY. 2011. 69(6);1248-1254. SUMMARY: PEDUNCULOPONTINE NUCLEUS (PPN) STIMULATION IS A NOVEL THERAPY FOR PARKINSON DISEASE. HOWEVER, CONTROVERSIES REMAIN REGARDING THE CLINICAL APPLICATION OF THIS NEW THERAPY, INCLUDING PATIENT SELECTION, ELECTRODE POSITIONING, AND HOW BEST TO ASSESS OUTCOMES. THE OBJECTIVE WAS TO CLARIFY THE CLINICAL APPLICATION OF PPN STIMULATION IN PARKINSON DISEASE. FIVE CONSECUTIVE PATIENTS WITH PARKINSON DISEASE COMPLICATED BY SEVERE GAIT FREEZING, POSTURAL INSTABILITY, AND FREQUENT FALLS (ALL PERSISTING EVEN WHILE THE PATIENT WAS ON MEDICATION) RECEIVED BILATERAL STIMULATION OF THE MID-LOWER PPN WITHOUT COSTIMULATION OF OTHER BRAIN TARGETS. OUTCOMES WERE ASSESSED PROSPECTIVELY OVER 2 YEARS WITH GAIT-SPECIFIC QUESTIONNAIRES AND THE UNIFIED PARKINSON DISEASE RATING SCALE (PART III). THE PRIMARY OUTCOME, THE GAIT AND FALLS QUESTIONNAIRE SCORE, IMPROVED SIGNIFICANTLY WITH STIMULATION. BENEFITS WERE MAINTAINED OVER YEARS. UNIFIED PARKINSON DISEASE RATING SCALE (PART III) ITEMS ASSESSING GAIT AND POSTURE WERE RELATIVELY INSENSITIVE TO THESE TREATMENT EFFECTS. BENEFICIAL EFFECTS OFTEN APPEARED TO OUTLAST STIMULATION FOR HOURS OR LONGER. THUS, SINGLE-SESSION ON- VS OFF-STIMULATION ASSESSMENTS MAY BE SUSCEPTIBLE TO "DELAYED WASHOUT EFFECTS." STIMULATION OF THE PPN DID NOT CHANGE AKINESIA SCORES OR DOPAMINERGIC MEDICATION REQUIREMENTS. BILATERAL STIMULATION OF THE MID-LOWER PPN (MORE CAUDAL THAN PREVIOUS REPORTS) WITHOUT COSTIMULATION OF OTHER BRAIN TARGETS MAY BE BENEFICIAL FOR THE SUBGROUP OF PATIENTS WITH PARKINSON DISEASE WHO EXPERIENCE SEVERE GAIT FREEZING AND POSTURAL INSTABILITY WITH FREQUENT FALLS, WHICH PERSIST EVEN WHILE ON MEDICATION. CHOOSING APPROPRIATE OUTCOME MEASURES AND ACCOUNTING FOR THE POSSIBILITY OF PROLONGED STIMULATION WASHOUT EFFECTS APPEAR TO BE IMPORTANT FOR DETECTING THE CLINICAL BENEFITS. REPORTABLE EVENT: IN ONE PATIENT, 1 ELECTRODE WAS FOUND TO BE MALPOSITIONED TOO VENTRALLY AND WAS REPLACED 2 DAYS AFTER THE INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3387

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL#