MAUDE Adverse Event Report: BRAINSWAY LTD. DEEP TMS SYSTEM; TRANSCRANIAL MAGNETIC STIMULATION (TMS)

Model Number	104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Known ae of tms.
Event or Problem Description
Patient experienced a tonic-clonic seizure during treatment session #3, with labored breating and oral secretions.Seizure was resolved within 2 minutes.Initially, patient was lethargic confused and not oriented, although the patient's sensorium cleared and patient became more alert and conversant within a few minutes.Patient was sent to the er.Ct and blood work were normal.No seizure history or family seizure history and no sleep deprivation.This was probably a tms-provoked seizure.

• Brand Name: DEEP TMS SYSTEM
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATION (TMS)
• Manufacturer (Section D): BRAINSWAY LTD.; 16 hartom str.; har hotzvim; jerusalem, 97775 16; IS 9777516
• Manufacturer (Section G): BRAINSWAY LTD.; 16 hartom str.; har hotzvim; jerusalem, 97775 16; IS 9777516
• Manufacturer Contact: neta sherman ; 16 hartom str.; har hotzvim; jerusalem, 97775-16 ; IM 9777516
• MDR Report Key: 21771664
• Report Number: 3010300912-2025-18376
• Device Sequence Number: 15503824
• Product Code: OBP
• UDI-Device Identifier: 07290110538026
• UDI-Public: (01)07290110538026(11)230131
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K173540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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: 104
• Device Catalogue Number: SYS-104-001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Sex: Female