BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HORIZON TMS THERAPY SYSTEM

    MDR report key: 10533918 · Received September 15, 2020

    Report

    Report Number
    8021774-2020-00006
    Event Type
    Injury
    Date Received
    September 15, 2020
    Report Date
    May 4, 2021
    Manufacturer
    THE MAGSTIM COMPANY LTD.
    Product Code
    OBP
    PMA / PMN Number
    K182853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: MAGSTIM HAS INVESTIGATED THE DEVICE IN QUESTION. WITHIN THE HORIZON TMS THERAPY SYSTEM (HORIZON PERFORMANCE), THE MAGNETIC STIMULATION IS DELIVERED VIA THE E-Z COOL COIL, WHICH GENERATES A SOUND OUTPUT DUE BOTH TO THE GENERATION OF THE MAGNETIC PULSE AND THE SOUND OF THE FAN, USED FOR COOLING THE E-Z COOL COIL. AS SUCH, ACOUSTIC TESTING WAS CONDUCTED ON THE E-Z COOL COIL WITH SERIAL NUMBER (B)(6) WHICH WAS RECEIVED BACK FROM THE CUSTOMER BY MAGSTIM. THE ACOUSTIC OUTPUT OF THE E-Z COOL COIL RETURNED FROM THE CUSTOMER WAS COMPARED WITH A COMPARATOR COIL AND WITH THE INITIAL ACOUSTIC MEASUREMENTS FROM A PROTOTYPE COIL DURING DEVELOPMENT. IT WAS CONCLUDED FROM THE TESTING THAT THE RETURNED E-Z COOL COIL WAS WITHIN THE SAME SOUND PRESSURE EXPOSURE LEVELS AS THE COMPARATOR COIL TESTED, AND THE OPERATOR/PATIENT EXPOSURE LEVELS OF BOTH THESE COILS ARE QUIETER THAN THE ORIGINAL RESULTS FROM THE PROTOTYPE COIL. ONLY AT A 0CM DISTANCE FROM THE RETURNED E-Z COOL COIL DID THE SOUND PRESSURE MEASUREMENT EXCEED THE ABSOLUTE MAXIMUM ACTION VALUE OF 87DB (A-WEIGHTED) UNDER THE CONTROL OF NOISE AT WORK REGULATIONS 2005. MAGSTIM ALSO ADVISES WITHIN THE OPERATING MANUAL FOR THE HORIZON PERFORMANCE THAT HEARING PROTECTION FOR THE OPERATOR 'IS ADVISED IF HE OR SHE IS LOCATED WITHIN 6 FEET (2 METERS) OF THE COIL'. INFORMATION PROVIDED BY BERRYWOOD HOSPITAL INDICATED THAT THE OPERATOR WAS WEARING EAR PLUGS. THE NOISE OF THE HORIZON PERFORMANCE IS A KNOWN RISK AND THERE IS A WARNING TO THIS EFFECT IN THE OPERATING MANUAL WITH ADVICE ON MITIGATIONS FOR THE PATIENT AND OPERATOR. AS THERE IS NO EVIDENCE THAT THE ACOUSTIC OUTPUT OF THE E-Z COOL COIL RETURNED WAS HIGHER THAN EXPECTED, REVIEW OF THE INVESTIGATION DATA AVAILABLE SUGGESTS THAT HORIZON PERFORMANCE HAS NOT CONTRIBUTED TO, NOR CAUSED, SERIOUS INJURY TO THE OPERATOR. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE INCIDENT. CORRECTED/AMENDED DATA: 1) PLEASE NOTE A CORRECTION FROM THE INITIAL REPORT PREVIOUSLY PROVIDED FOR THIS MATTER. IN THE INITIAL REPORT IT WAS INCORRECTLY IDENTIFIED IN SECTION D.10 THAT THIS SYSTEM INCLUDED A HORIZON AIR FILM COIL (P/N 4980-00 WITH SERIAL NUMBER 503) WHEN IN FACT IT INCLUDED A HORIZON E-Z COOL COIL (P/N 4999-00 WITH SERIAL NUMBER 0092). THE HORIZON E-Z COOL COIL DETAILS HAVE BEEN INCLUDED IN SECTION D.10 OF THIS REPORT. ALSO, THE INITIAL REPORT LISTED THE CATALOGUE NUMBER IN SECTION D.4 AS 4950-00 WHICH IS THE HORIZON MAINFRAME WITH THE APPLICABLE SERIAL NUMBER. SINCE THIS INCIDENT RELATES TO AN INVESTIGATION OF ACOUSTIC OUTPUT, AND THE SOUND IS PRODUCED BY THE COIL, THE CATALOGUE/REFERENCE NUMBER UNDER SECTION D.4 HAS NOW BEEN LISTED AS 4999-00 WITH THE APPROPRIATE SERIAL NUMBER NOW ALSO REVISED. 2) PLEASE NOTE THAT THE CONTACT FOR THIS REPORT IS NOW TOM CAMPBELL. THE CONTACT EMAIL AND TELEPHONE NUMBER REMAIN THE SAME AS PREVIOUSLY REPORTED. 3) PLEASE NOTE AN AMENDMENT FOR MEDICAL DEVICE PROBLEM CODE IN SECTION H.6 FROM 3190 INCLUDED IN THE INITIAL REPORT TO 2993 IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    MAGSTIM HAS ATTEMPTED PICK-UP OF THE COIL SEVERAL TIMES WITHOUT SUCCESS. PICK UP HAS BEEN RE-ARRANGED TO INVESTIGATE THE NOISE LEVELS RELATED TO THE COIL. 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 · 0

    THE PATIENT REPORTED THAT BEFORE STARTING THE RESEARCH PROJECT THEY HAD MILD SYMPTOMS OF TINNITUS FROM THE AGE OF 30. THIS HAS INCREASED SINCE WORKING ON THE RESEARCH PROJECT, DUE TO THE CONFINED SPACE TO WORK IN AND THE VOLUME OF THE MACHINE. EAR PLUGS WERE WORN WHICH WERE SUPPLIED BY THE UNIT. FOAM EAR PLUGS, THIS ENHANCED THE SOUND OF THEIR TINNITUS, ALSO EXPERIENCING THE FEEL OF WATER IN THEIR EAR AS THOUGH THE EAR IS BLOCKED, WHICH ENHANCES THE RINGING. THEY HAVE NOT HAD A HEARING TEST. THEY ARE NOT ON ANY MEDICATION FOR THIS. THESE SYMPTOMS DO GET THEM DOWN ESPECIALLY WHEN THEY'RE IN BED AT NIGHT WHEN EVERYTHING IS QUIET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STAFF MEMBER EXPERIENCED WORSENING OF TINNITUS. THIS WAS REPORTED TO RELATE TO THE USE OF THIS PARTICULAR HORIZON SYSTEM, DUE TO THE NOISE LEVELS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998477 HORIZON TMS THERAPY SYSTEM HORIZON OBP THE MAGSTIM COMPANY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other 4806-00 - HORIZON PSU - (B)(6)| 4806-00 HORIZON PSU - (B)(6)| 4950-00 - HORIZON MAINFRAME - (B)(6)| 4950-00 MAINFRAME - (B)(6)| 4980-00 HORIZON AIR FILM COIL - (B)(6)| 4999-00 - E-Z COOL COIL - (B)(6)| 5313-00 EZ CART ARM - (B)(6)| 4806-00 HORIZON PSU - SN 0056| 4950-00 MAINFRAME - SN 0056| 4980-00 HORIZON AIR FILM COIL - SN 503| 5313-00 EZ CART ARM - SN 00055971001