BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID

    MDR report key: 7959544 · Received October 12, 2018

    Report

    Report Number
    8021774-2018-00003
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    September 11, 2018
    Report Date
    September 12, 2018
    Manufacturer
    THE MAGSTIM COMPANY LIMITED
    Product Code
    OBP
    PMA / PMN Number
    K143531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVOLVED: 4800-00T - RAPID THERAPY SYSTEM, WHICH CONSISTED OF: 3012-00T - RAPID² MAINFRAME - SN (B)(4) - MANUFACTURING DATE NOVEMBER 2015; 3013-US - POWER SUPPLY UNIT - SN (B)(4) - MANUFACTURING DATE OCTOBER 2015; 3022-00T - USER INTERFACE - SN (B)(4) - MANUFACTURING DATE NOVEMBER 2015; 3801-01 - MAINS FILTER - SN (B)(4) - MANUFACTURING DATE OCTOBER 2015; 3910-00 - AIR FILM COIL - SN (B)(4) - MANUFACTURING DATE FEBRUARY 2016. INVESTIGATION INITIATED. EXEMPTION NUMBER E2018009. THE MAGSTIM COMPANY LIMITED (REGISTRATION NUMBER CFN 8021774) IS SUBMITTING THIS REPORT ON BEHALF OF MAGSTIM INC. (REGISTRATION NUMBER FEI 3011755356).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE EVENT INCLUDED A REVIEW OF THE PATIENT'S MEDICAL/PSYCHOLOGICAL HISTORY, A INSPECTION OF THE DEVICE AND DEVICE HISTORY, A TREND REVIEW IN RELATION TO THE FAILURE MODE OF 'SEIZURE', A REVIEW OF THE CLINICAL EVALUATION, A REVIEW OF THE MODE OF ACTION AND THE SCREENING OF THE PATIENT BY A TMS SCREENING QUESTIONNAIRE. THERE WAS NO EVIDENCE TO SUGGEST THAT THE TMS DEVICE INVOLVED WITH THE TREATMENT CONTRIBUTED TO THE EVENT REPORTED; THE DEVICES WERE RELEASED IN COMPLIANCE WITH THE SPECIFICATIONS AND WERE REPORTED TO OPERATE AS INTENDED AND TO BE IN GOOD CONDITION. A TREND REVIEW WAS PERFORMED, SEARCHING MAGSTIM'S COMPLAINT DATABASE ON ANY SIMILAR EVENTS OF SEIZURE, GOING BACK OVER 5 YEARS I.E. 2013-2018. THIS REVIEW DID NOT PRESENT ANY SIMILAR CASES OF SEIZURE DURING OR AFTER RTMS TREATMENT. A FINAL ROOT CAUSE OF THE SEIZURE COULD NOT BE ESTABLISHED, BUT COULD POTENTIALLY RELATE TO ANY OR A COMBINATION OF THE FOLLOWING FACTORS: COIL OR PATIENT MOVED DURING TREATMENT. INCORRECTLY POSITIONED COIL - USER ERROR. INCORRECTLY MEASURED MOTOR THRESHOLD - USER ERROR. INSUFFICIENT INFORMATION ON PREDISPOSITION OF THE PATIENT - USER ERROR. CORRECTIVE AND PREVENTIVE ACTIONS INCLUDED RE-TRAINING OF THE PERSONNEL AT THE CLINIC, AS WELL AS THE RECOMMENDATION TO USE THE PRE-SCREENING QUESTIONNAIRE TO DETERMINE THE PREDISPOSITION OF THE PATIENT IN RELATION TO RTMS TREATMENT. THIS QUESTIONNAIRE IS AVAILABLE IN MAGSTIM'S OPERATING MANUAL, AND MAGSTIM RECOMMENDS THAT THIS IS USED FOR THE SCREENING OF EVERY PATIENT. NO NEW REPORTS OF SEIZURES OR ANY OTHER ADVERSE EVENTS HAVE BEEN RECEIVED BY MAGSTIM FROM THIS CUSTOMER, NOR FROM ANY CUSTOMER GLOBALLY A MONTH AFTER THIS REPORT. THE FAILURE MODE OF 'SEIZURE' WILL BE MONITORED CLOSELY BY THE COMPANY'S COMPLAINTS PROCESS, AND WHERE A TREND EMERGES, APPROPRIATE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT CAME TO THE CUSTOMER FOR TRANSCRANIAL MAGNETIC STIMULATION FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER. INITIAL MAPPING WAS COMPLETED, THE MOTOR THRESHOLD DETERMINED TO BE 71%. TREATMENT WAS STARTED AT 60% DETERMINED BY THE PATIENT'S ABILITY TO TOLERATE. PROCEEDED WITH 10 TRAINS AT TOLERABLE POWER OF 60%. THE PATIENT BECAME LIGHTHEADED AND DISORIENTED. THE PROCEDURE WAS STOPPED. THE SUPERVISING PHYSICIAN TOOK THE PATIENT'S BLOOD PRESSURE: 96/68. COLD SWEAT OVER ENTIRE BODY, SIGNS OF POSSIBLE SEIZURE PRESENT: DISORIENTATIONS, CONFUSION, FEET TURNED INWARDS, EYES ROLLED BACK BRIEFLY. THE SEIZURE LASTED APPROXIMATELY 2 MINUTES. THE SUPERVISING PHYSICIAN STAYED WITH THE PATIENT UNTIL ORIENTATED AND BLOOD PRESSURE RETURNED TO NORMAL. THE PATIENT WAS ALLOWED TO LEAVE THE OFFICE AS PHYSICAL AND MENTAL SYMPTOMS ABATED. THE PATIENT WAS REFERRED TO PRIMARY (PCP) AND CARDIOLOGIST FOR RECOMMENDED EEG AND EKG. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN DUE TO UNSUCCESSFUL ATTEMPTS MADE BY THE PRACTICE TO REACH THE PATIENT BY PHONE OR EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800544 RAPID RAPID² THERAPY SYSTEM OBP THE MAGSTIM COMPANY LIMITED 4800-00T

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other PROZAC 20MG| PROZAC 20MG