BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGSTIM 200 & BISTIM TMS SYSTEMS AND MAGSTIM D70 COIL

    MDR report key: 23324568 · Received October 17, 2025

    Report

    Report Number
    8021774-2025-00002
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    July 1, 2025
    Report Date
    September 17, 2025
    Manufacturer
    THE MAGSTIM COMPANY LTD
    Product Code
    GWF
    UDI-DI
    05060229530424
    PMA / PMN Number
    K060847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE AUTHOR OF THE RELATED REPORT TO DETERMINE IF THE DEVICE WAS USED IN ACCORDANCE WITH THE IFU OR IF ANY MALFUCTIONS WERE NOTICED BEFORE USE.

    Description of Event or Problem · 0

    A MAGSTIM EMPLOYEE READ AN ARTICLE WHEREBY A 59-YEAR-OLD MALE STROKE SURVIVOR UNDERWENT SINGLE-PULSE TMS USING A BISTIM AND D70 COIL. APPROXIMATELY 5 MIN POST-STIMULATION, HE DEVELOPED A GENERALIZED TONIC-CLONIC SEIZURE. MULTIPLE SEIZURES FOLLOWED DURING TRANSPORT AND HOSPITAL ADMISSION. HE RECOVERED AFTER 2 DAYS. NO REPORTS OF THIS EVENT WERE MADE TO MAGSTIM DIRECTLY, THE INVESTIGATORS CONDUCTING THE TMS STUDY (THE AUTHORS OF THE PAPER) REPORTED THE EVENT TO THE METROHEALTH INSTITUTIONAL REVIEW BOARD (IRB). PAPER CITATION: YUK, J., HOGAN, S., WILSON, R. D., KNUTSON, J., & CUNNINGHAM, D. A. (2025). GENERALIZED TONIC-CLONIC SEIZURE FOLLOWING SINGLE-PULSE TRANSCRANIAL MAGNETIC STIMULATION TO THE IPSILESIONAL PRIMARY MOTOR CORTEX IN A PARTICIPANT WITH CHRONIC STROKE. CLINICAL NEUROPHYSIOLOGY, 178, 2110944. NO FURTHER INFORMATION WAS PROVIDED BY THE AUTHOR OF THE PAPER FOLLOWING 3 ATTEMPTS TO CONTACT THEM BY MAGSTIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298591 MAGSTIM 200 & BISTIM TMS SYSTEMS AND MAGSTIM D70 COIL MAGSTIM 200 & BISTIM TMS SYSTEMS AND MAGSTIM D70 COIL GWF THE MAGSTIM COMPANY LTD 3010-00 05060229530424

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other| H