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

Model Number	104
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After internal medical review, the seizure is likely associated with a genetic predisposition for seizures and a high motor threshold.According to the device instructions for use - the device should not have been used on a patient with a first degree relative with a history seizures.The company's medical affairs team had a discussion with the provider to discuss the event and provide further education and awareness surrounding best practices for motor threshold procedures and the influence of family history of seizures on a patient's propensity for this type of event.
Event or Problem Description
39 year old patient with mdd has a seizure during tms treatment session #23.Patient was unresponsive for approximately 12 seconds, lost bladder control and vomited.Patient was post ictal for approximately 25 minutes.Patient was evaluated in the er and released following no abnormal findings on ct.The only remarkable findings from er was a uti.The patient has a father and brother with a history seizures.Furthermore, the patient's motor threshold was relatively high.Consequently, after internal medical review, the seizure is likely associated with a genetic predisposition for seizures and a high motor threshold.

• 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, israel 97775-16 ; IS 9777516
• MDR Report Key: 24921078
• Report Number: 3010300912-2026-23727
• Device Sequence Number: 10671587
• Product Code: OBP
• UDI-Device Identifier: 07290110538026
• UDI-Public: (01)07290110538026(11)250121
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2026

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: 02/27/2026
• Initial Report FDA Received Date: 04/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRISTIQUE 50 MG.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female