BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HORIZON PERFORMANCE

    MDR report key: 10689025 · Received October 16, 2020

    Report

    Report Number
    8021774-2020-00007
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 2, 2020
    Manufacturer
    THE MAGSTIM COMPANY LTD.
    Product Code
    OBP
    PMA / PMN Number
    K182853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE FAILURE CAUSED OR CONTRIBUTED TO THE EVENT REPORTED. AS CONFIRMED BY THE TREATING PHYSICIAN, THE ISSUE IS ''MOST LIKELY NOT RELATED TO TMS. SHE HAD 5 TEST PULSES AND WAS BELOW THE MOTOR THRESHOLD. SHE AND HER MOTHER BOTH HAVE A HISTORY OF SIMILAR ATTACKS WHEN ANXIOUS.'' IT WAS REPORTED THAT THE PATIENT WOULD SEE HER PCP ON THE DAY OF THE INCIDENT AND WAS RECOMMENDED A NEUROLOGY EVALUATION. FURTHER INFORMATION HAS NOT BEEN RECEIVED. A FINAL ROOT CAUSE COULD NOT BE CONFIRMED, HOWEVER, WITH THE ABOVE INFORMATION MAGSTIM IS CONFIDENT THAT THE ISSUE IS MOST LIKELY NOT RELATED TO THE DEVICE AND ITS TREATMENT THAT WAS BEING PROVIDED AT THE TIME OF THE INCIDENT. THIS EVENT IS THEREFORE REPORTED TO YOU TO ERR ON THE SIDE OF CAUTION. THE DEVICE IS MOST LIKELY NOT RELATED TO THE REPORTED EVENT, AND THEREFORE REPORTING HAS BEEN PERFORMED TO ERR ON THE SIDE OF CAUTION, WHERE IT IS ALSO DIFFICULT TO ASSESS HOW SERIOUS THE LOSS OF CONSCIOUSNESS WAS, AS THIS COULD POTENTIALLY DEPEND ON THE CAUSE OF THE EVENT (E.G. NEUROLOGICAL - ABSENCE SEIZURE, VASOVAGAL). AS THE DEVICE IS MOST LIKELY NOT RELATED TO THE INCIDENT, NO CORRECTIVE AND PREVENTIVE ACTIONS ARE REQUIRED. THE EVENT WILL BE MONITORED IN LINE WITH THE COMPANY'S TREND ANALYSIS FOR COMPLAINTS. SIMILAR EVENTS WERE BASED ON ALL 'LOSS OF CONSCIOUSNESS', 'SEIZURE', AND 'FAINTING' INCIDENTS IN RELATION TO THE HORIZON PERFORMANCE, SINCE ITS LAUNCH IN NOVEMBER 2017. ONE EVENT (OUR REF (B)(4)) REPORTED A POTENTIAL SEIZURE DURING THE (B)(6) STUDY. IN CONFIRMATION TO MAGSTIM, THE PRINCIPLE INVESTIGATOR CONFIRMED THAT THE PATIENT WAS ASSESSED BY THE CONSULTANT NEUROLOGIST AND HAD BOTH EEG AND MRI IN THE WEEKS FOLLOWING THE SUSPECTED SEIZURE. THE RESULTS OF THE EEG AND MRI WHERE REVIEWED BY THE CONSULTANT NEUROLOGIST WITH NEITHER SHOWING ANY CLASSICAL SIGNS OF SEIZURE ACTIVITY. THE CLINICAL DECISION OF THE NEUROLOGIST WAS THAT THE SYMPTOMS PRESENTED BY THE PATIENT DURING THE TRIAL WAS UNLIKELY TO BE A SEIZURE, AND AS SUCH BY AGREEMENT OF THE BRIGHTMIND CHIEF INVESTIGATOR, THE CLASSIFICATION WITHIN THE TRIAL DOWNGRADED FROM SERIOUS ADVERSE EVENT TO ADVERSE EVENT. THE PRINCIPLE INVESTIGATOR ALSO CONFIRMED THAT THE SUSPECTED SEIZURE DID NOT OCCUR DURING THE TMS STIMULATION SESSION, BUT IN THE DAYS FOLLOWING STIMULATION, AND THEREFORE, THE SYMPTOMS PRESENTED NOT LIKELY ATTRIBUTED TO THE TMS STIMULATION. AS SUCH, SUBSEQUENT REVIEW OF THE INVESTIGATION DATA AVAILABLE SUGGESTS THAT HORIZON HAS NOT ATTRIBUTED TO, NOR CAUSED SERIOUS INJURY TO THE PATIENT. THE MAGSTIM COMPANY LTD. IS, AS PER YOUR REQUEST, CURRENTLY IN THE PROCESS OF SETTING UP A WEBTRADER ACCOUNT FOR MAGSTIM INC. USA. DURING THIS TRANSITION TIME, PLEASE ACCEPT THIS SUBMISSION AS OF THE MAGSTIM COMPANY LTD. AND MAGSTIM INC. USA BOTH. EXEMPTION NUMBER E2018009. THE MAGSTIM COMPANY LIMITED (REGISTRATION NUMBER CFN 8021774) IS SUBMITTING THIS REPORT ON BEHALF OF MAGSTIM INC. (REGISTRATION NUMBER FEI 3011755356).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM TREATING MD: ''PT. WAS SEEN FOR INITIAL TMS MAPPING. DURING THE PROCEDURE SHE SAT FORWARD, PUT HER HEAD IN HER HANDS AND SAID, "DR. (B)(6) I HAVE VASOVAGAL REACTIONS." AND ASKED IF SHE WAS HAVING ONE NOW SHE NODDED HER HEAD. WE RECLINED HER IN THE TMS CHAIR, AND SHE WAS NOTED TO BE STARING STRAIGHT A HEAD, UNRESPONSIVE TO VOICE, LIGHT OR DEEP PAIN STIMULI. PUPILS WERE FULL DILATED, 1MM IRIS SHOWING, AND UNRESPONSIVE TO LIGHT. SHE WAS NOT STILL, NOT MOVING, BUT THERE WAS ONE TWITCH IN HER LEFT ELBOW DURING THE EPISODE. SHE CONTINUED UNRESPONSIVE FOR 5 MIN. SHE RECOVERED GRADUALLY, WAS ABLE TO SPEAK A LITTLE, JUST SAID SHE WASN'T FEELING WELL. HER PUPILS WERE STILL DILATED AND SHE SAID SHE COULD NOT SEE ANYTHING, IT WAS "LIKE TV" BUT COULDN'T ELABORATE. IN ANOTHER 3 MIN HER VISION RECOVERED, HER PUPILS RELAXED TO 8MM, AND SHE WAS FULLY ALERT AND RESPONSIVE. SHE HAD NO RECOLLECTION OF EVENTS DURING THE UNRESPONSIVE PERIOD. WITHIN A MINUTE OF RECOVERING HER VISION, SHE VERY ABRUPTLY STARTED SOBBING, AND CRIED FOR ABOUT 5 MIN MORE. SHE SAID SHE WAS UPSET BECAUSE SHE WAS HOPING THE TMS WOULD HELP HER. 15 MIN AFTER THE EPISODE STARTED, SHE WAS CALM, NOT CRYING, AAORX3, BUT STILL DID NOT FEEL FULLY CLEAR HEADED. WE CALLED HER MOTHER TO PICK HER UP. MOTHER NOTED THAT SHE HAS HAD OTHER EPISODES OF LOC, AND WAS UNABLE TO SEE FOR A SHORT TIME WHEN SHE WOKE UP FROM THOSE EPISODES, BUT THEY WERE THOUGHT TO BE VASOVAGAL REACTIONS FROM ANXIETY. J (RED) HAD BEEN ON TRINTELLIX, STOPPED IT DUE TO SIDE EFFECTS AND HAS BEEN MORE ANXIOUS SINCE STOPPING IT. IMPRESSION: VASOVAGAL REACTION. R/O ABSENCE SEIZURE. HER MOTHER HAS HAD SIMILAR EPISODES, AS HAS J (RED). THE SLOW RECOVERY, PERSISTING OF VISION LOSS, AND BRIEF PERIOD OF CONFUSION AFTER REGAINING CONSCIOUSNESS SEEM TO ME TO BE UNUSUAL FOR A VASOVAGAL REACTION. SHE WILL SEE HER PCP TODAY AND I AM RECOMMENDING A NEUROLOGY EVALUATION.''

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156233 HORIZON PERFORMANCE HORIZON PERFORMANCE OBP THE MAGSTIM COMPANY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other