BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINDMOTIONPRO

    MDR report key: 7323802 · Received March 8, 2018

    Report

    Report Number
    3013517146-2018-00001
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    July 3, 2017
    Report Date
    July 12, 2017
    Manufacturer
    MINDMAZE SA
    Product Code
    LXJ
    PMA / PMN Number
    K162748
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS RETROSPECTIVELY FILED WITH US FDA BASED ON THE RESULTS OF A QUALITY AUDIT, OF MINDMAZE (B)(4). IT WAS NOT KNOWN TO THE STAFF PRESENT (DURING THE EVENT) OR THE MINDMAZE REPRESENTATIVES THAT THE PATIENT WAS ON ANTI-EPILEPTIC MEDICATION. PATIENT WAS HAPPY, ALERT AND ORIENTATED ON ARRIVAL. SHE HAS EXPRESSIVE APHASIA BUT HAD COMMUNICATED CONSENT VIA HER COMMUNICATION BOARD TO USE THE MMPRO. AFTER THE SESSION WAS COMMENCED THE PATIENT STARTED TO DEMONSTRATE INVOLUNTARY MOVEMENTS OF HER HEAD AND NECK. PATIENT WAS ASKED IF SHE WAS OK AND HAPPY TO CONTINUE AND SHE REPORTED YES. HOWEVER, THE INVOLUNTARY MOVEMENTS STARTED TO BECOME MORE EXAGGERATED AND TRANSLATED TO HER ARM AND TRUNK. STAFF PRESENT WERE NOT FAMILIAR WITH THE PRESENTATION OF THE PATIENT SO COULD NOT ADVISE. THUS, MEDICAL STAFF WERE BLEEPED AND OBSERVATIONS OF THE PATIENT WERE TAKEN WHICH WERE ALL NORMAL. DURING THIS TIME THE PATIENT BECAME TEARFUL. THE DOCTOR WHO ARRIVED WAS FAMILIAR WITH THE PATIENT AND WITH HER PRESENTATION, SHE EXPRESSED SHE WAS TEARFUL AND SHE WAS SCARED. HE CONDUCTED A NEUROLOGICAL ASSESSMENT AND REPORTED THAT SHE HAD EXPERIENCED AN EPILEPTIC SEIZURE AND THAT HER MEDICATION WOULD BE REVIEWED BUT REPORTED HER TO BE MEDICALLY STABLE AND WELL. THE SESSION WAS CEASED AND THE PATIENT WAS RETURNED TO HER ROOM BY THIS TIME WAS ONCE AGAIN CALM AND HAPPY. THE USER MANUAL FOR THE MMPRO DEVICE STATES, AS A SIDE EFFECT, THAT "THERE IS A SMALL POSSIBILITY OF AN EPILEPTIC SEIZURE BEING PROVOKED BY PHOTIC STIMULATION. SHOULD THIS OCCURS, STOP USING MINDMOTIONPRO IMMEDIATELY". THIS EVENT WAS REPORTED TO THE (B)(6). (B)(4).

    Description of Event or Problem · 1

    DURING THE TRAINING AT THE (B)(6), THE FIRST PATIENT WHO TRIED THE MINDMOTION PRO EXPERIENCED A MILD SEIZURE DURING THE USE OF THE DEVICE. THERAPY WAS STOPPED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168703 MINDMOTIONPRO SYSTEM, OPTICAL POSITION/MOVEMENT RECORDING LXJ MINDMAZE SA

    Patients

    Seq Age Sex Outcome Treatment
    1