MAUDE Adverse Event Report: THE MAGSTIM COMPANY LTD MAGSTIM 200 & BISTIM TMS SYSTEMS AND MAGSTIM D70 COIL

Model Number	3010-00
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Convulsion, Clonic (2222); Convulsion, Tonic (2223); Convulsion/Seizure (4406)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: MAGSTIM 200 & BISTIM TMS SYSTEMS AND MAGSTIM D70 COIL
• Common Device Name: MAGSTIM 200 & BISTIM TMS SYSTEMS AND MAGSTIM D70 COIL
• Manufacturer (Section D): THE MAGSTIM COMPANY LTD; spring gardens; whitland, carmarthenshire SA34 0HR; UK SA34 0HR
• Manufacturer (Section G): THE MAGSTIM COMPANY LTD; spring gardens; whitland, carmarthenshire SA34 0HR; UK SA34 0HR
• Manufacturer Contact: louise prentice ; spring gardens; whitland, carmarthenshire SA34 -0HR ; UK SA34 0HR
• MDR Report Key: 23324568
• Report Number: 8021774-2025-00002
• Device Sequence Number: 15930188
• Product Code: GWF
• UDI-Device Identifier: 05060229530424
• UDI-Public: 05060229530424
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3010-00
• Device Catalogue Number: 3010-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male