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

Model Number	104
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The causes of the seizure were multifactorial.Transgender individual with mdd at increased risk for substance use, which may affect treatment safety and medication compliance.Left hand movement during h-7 treatment during the full course of treatment, indicating cortical spread or priming to the right cortex and lowering of motor threshold, was not recognized as cortical hyperexcitability indicator requiring treatment modification.Patient was treated with dual treatment stimulation protocol, which is outside of the approved instructions for use (i.E., off label use).This was a device-induced focal motor seizure (jacksonian seizure) that was highly preventable through proper risk assessment, protocol adherence, and recognition of warning signs.Multiple failures converged to create an unsafe treatment environment that directly contributed to this serious adverse event.
Event or Problem Description
Patient experienced a tonic-clonic seizure during second stage of dual coil treatment (h7 - itbs and then h1 depression protocol, occured during train 34/55 of depression protocol reatment).Seizure lasted approximately 3 minutes.Post-ictal confusion present.Patient refused to be transferred to er.No sleep deprivation.The causes of the seizure were multifactorial.Transgender individual with mdd at increased risk for substance use, which may affect treatment safety and medication compliance.Left hand movement during h-7 treatment during the full course of treatment, indicating cortical spread or priming to the right cortex and lowering of motor threshold, was not recognized as cortical hyperexcitability indicator requiring treatment modification.Patient was treated with dual treatment stimulation protocol, which is outside of the approved instructions for use (i.E., off label use).This was a device-induced focal motor seizure (jacksonian seizure) that was highly preventable through proper risk assessment, protocol adherence, and recognition of warning signs.Multiple failures converged to create an unsafe treatment environment that directly contributed to this serious adverse event.

• Brand Name: DEEP TMS SYSTEM
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATION (TMS)
• Manufacturer (Section D): BRAINSWAY LTD.,; 16 hartum str.; jerusalem, 97775 16; IS 9777516
• Manufacturer (Section G): BRAINSWAY LTD.; 16 hartum str.; jerusalem, 97775 16; IS 9777516
• Manufacturer Contact: neta sherman ; 16 hartum str.; jerusalem, 97775-16 ; IS 9777516
• MDR Report Key: 22466358
• Report Number: 3010300912-2025-19948
• Device Sequence Number: 15438990
• Product Code: OBP
• UDI-Device Identifier: 07290110538026
• UDI-Public: (01)07290110538026(11)210225
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 06/17/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2021
• 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: CREON 12000, 38000, 60000 CAPSULES DELAYED RELEASE; GENDER-AFFIRMING HORMONE THERAPY NOT DOCUMENTED; LAMOTRIGINE 150 MG DAILY; LITHIUM CARBONATE XL 450MG 2 TABLETS BID (1800MG); OLANZAPINE 7.5 MG DAILY; PROPRANOLOL 20 MG DAILY; THIAMINE HCL 100 MG DAILY; VIBERZI 75 MG DAILY; WELLBUTRIN XL 150 MG DAILY; WESTAB 2.5 MG DAILY
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Sex: Female