MAUDE Adverse Event Report: BRAINSWAY LTD. DEEP TRANSCRANIAL MAGNETIC STIMULATOR

Model Number	104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion, Clonic (2222)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Known and anticipated adverse event of tms.
Event or Problem Description
Approximately three minutes into the 23rd treatment using the brainsway h1 treatment (theta-burst 600 pulse protocol), the patient began to have contractions of her right hand which steadily progressed up to the arm in a jacksonian manner.The patient alerted the technician that their hand was cramping.The technician stopped the machine, moved the patient to the floor, notified ems and the nurse practitioner.The patient began to have a generalized tonic-clonic seizure which lasted 1.5 minutes followed by a 5-7 minute postictal period.The patient was transported to a local emergency room.A ct scan showed no remarkable findings.This appears to have been a seizure with no known precipitating factors.

• Brand Name: DEEP TRANSCRANIAL MAGNETIC STIMULATOR
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): BRAINSWAY LTD.; 16 hartom str.; har hahotzvim; jerusalem, israel 97775 16; IS 9777516
• Manufacturer (Section G): BRAINSWAY LTD.; 16 hartom str.; har hahotzvim; jerusalem, israel 97775 16; IS 9777516
• Manufacturer Contact: neta sherman ; 16 hartom str.; har hahotzvim; jerusalem, 97775-16 ; IS 9777516
• MDR Report Key: 25571926
• Report Number: 3010300912-2026-24722
• Device Sequence Number: 13002902
• Product Code: OBP
• UDI-Device Identifier: 07290110538026
• UDI-Public: (01)07290110538026(11)211111
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLONAZEPAM 0.5MG.; VIIBRYD 10 MG.VYVANSE 40 MG.CLONAZEPAM 0.5MG.; VYVANSE 40 MG.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female