BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7614429 · Received June 19, 2018

    Report

    Report Number
    3007566237-2018-01821
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    April 10, 2018
    Report Date
    June 19, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EQUAL NUMBER OF MEN AND WOMEN; THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: NUIC, D., VINTI, M., KARACHI, C., FOULON, P., VAN HAMME, A., WELTER, ML. THE FEASIBILITY AND POSITIVE EFFECTS OF A CUSTOMISED VIDEOGAME REHABILITATION PROGRAMME FOR FREEZING OF GAIT AND FALLS IN PARKINSON'S DISEASE PATIENTS: A PILOT STUDY. J NEUROENG REHABIL. 2018;15(1):31. DOI: 10.1186/S12984-018-0375-X. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    SUMMARY: FREEZING OF GAIT AND FALLS REPRESENT A MAJOR BURDEN IN PATIENTS WITH ADVANCED FORMS OF PARKINSON¿S DISEASE (PD). THESE AXIAL MOTOR SIGNS ARE NOT FULLY ALLEVIATED BY DRUG TREATMENT OR DEEP-BRAIN STIMULATION. RECENTLY, VIRTUAL REALITY HAS EMERGED AS A REHABILITATION OPTION FOR THESE PATIENTS. IN THIS PILOT STUDY, WE AIM TO DETERMINE THE FEASIBILITY AND ACCEPTABILITY OF REHABILITATION WITH A CUSTOMISED VIDEOGAME TO TREAT GAIT AND BALANCE DISORDERS IN PD PATIENTS, AND ASSESS ITS EFFECTS ON THESE DISABLING MOTOR SIGNS. METHODS: WE DEVELOPED A CUSTOMISED VIDEOGAME DISPLAYED ON A SCREEN USING THE KINECT SYSTEM. TO PLAY, THE PATIENT HAD TO PERFORM LARGE AMPLITUDE AND FAST MOVEMENTS OF ALL FOUR LIMBS, PELVIS AND TRUNK, IN RESPONSE TO VISUAL AND AUDITORY CUEING, TO DISPLACE AN AVATAR TO COLLECT COINS AND AVOID OBSTACLES TO GAIN POINTS. WE TESTED TEN PATIENTS WITH ADVANCED FORMS OF PD (MEDIAN DISEASE DURATION = 16.5 YEARS) SUFFERING FROM FREEZING OF GAIT AND/OR FALLS (HOEHN & YAHR SCORE = 3) RESISTANT TO ANTIPARKINSONIAN TREATMENT AND DEEP BRAIN STIMULATION. PATIENTS PERFORMED 18 TRAINING SESSIONS DURING A 6¿9 WEEK PERIOD. WE MEASURED THE FEASIBILITY AND ACCEPTABILITY OF OUR REHABILITATION PROGRAMME AND ITS EFFECTS ON PARKINSONIAN DISABILITY, GAIT AND BALANCE DISORDERS (WITH CLINICAL SCALES AND KINEMATICS RECORDINGS), POSITIVE AND NEGATIVE AFFECTS, AND QUALITY OF LIFE, AFTER THE 9TH AND 18TH TRAINING SESSIONS AND 3 MONTHS LATER. RESULTS: ALL PATIENTS COMPLETED THE 18 TRAINING SESSIONS WITH HIGH FEASIBILITY, ACCEPTABILITY AND SATISFACTION SCORES. AFTER TRAINING, THE FREEZING-OF-GAIT QUESTIONNAIRE, GAIT-AND-BALANCE SCALE AND AXIAL SCORE SIGNIFICANTLY DECREASED BY 39, 38 AND 41%, RESPECTIVELY, AND THE ACTIVITY-BALANCE CONFIDENCE SCALE INCREASED BY 35%. KINEMATIC GAIT PARAMETERS ALSO SIGNIFICANTLY IMPROVED WITH INCREASED STEP LENGTH AND GAIT VELOCITY AND DECREASED DOUBLE-STANCE TIME. THREE MONTHS AFTER THE FINAL SESSION, NO SIGNIFICANT CHANGE PERSISTED EXCEPT DECREASED AXIAL SCORE AND INCREASED STEP LENGTH AND VELOCITY. CONCLUSIONS: THIS STUDY SUGGESTS THAT REHABILITATION WITH A CUSTOMISED VIDEOGAME TO TREAT GAIT AND BALANCE DISORDERS IS FEASIBLE, WELL ACCEPTED, AND EFFECTIVE IN PARKINSONIAN PATIENTS. THESE DATA SERVE AS PRELIMINARY EVIDENCE FOR FURTHER LARGER AND CONTROLLED STUDIES TO PROPOSE THIS CUSTOMISED VIDEOGAME REHABILITATION PROGRAMME AT HOME. REPORTED EVENTS: 1. PATIENT 6: A (B)(6)-YEAR-OLD MALE PATIENT WITH SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) REQUIRED IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT FOR AN UNSPECIFIED REASON. 2. PATIENT 9: A (B)(6)-YEAR-OLD FEMALE PATIENT WITH STN-DBS FOR PD REQUIRED INS REPLACEMENT FOR AN UNSPECIFIED REASON. 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
    459301 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention