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

Model Number	104
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Contributing factors analysis: patient-related risk factors: medication: patient prescribed vyvanse (lisdexamfetamine), which is known to lower seizure threshold.Substance use: positive drug screen for thc (marijuana), which may affect seizure susceptibility.Additional undisclosed substance use cannot be ruled out and may have further contributed to seizure risk.Potential alcohol use: staff reported patient was known to "party" and may have consumed alcohol despite denial, though this remains unconfirmed.Device/procedural factors: equipment adjustments: helmet positioning and treatment location modifications were made during the session in response to patient discomfort.Motor threshold compliance: motor threshold (mt) was not being rechecked weekly as required by manufacturer guidelines, potentially resulting in inappropriate treatment parameters.Patient monitoring: technician was working on a computer with back turned to the patient when the seizure occurred, representing a significant deviation from required continuous patient observation protocols.Safety protocol adherence: multiple procedural violations including inadequate patient monitoring and failure to maintain proper calibration schedules.Conclusions: this seizure incident resulted from a convergence of both patient-specific risk factors and significant procedural/device-related protocol violations.The patient's medication regimen (vyvanse) and substance use (marijuana) created an elevated baseline seizure risk, while multiple procedural deviations, including failure to maintain weekly motor threshold recalibration per manufacturer guidelines and inadequate patient monitoring during active treatment, created unsafe treatment conditions.Both the patient's underlying condition and risk factors, as well as device-related procedural factors and protocol violations, contributed to the occurrence of this seizure event.The service team investigation included device inspection, however, the inability to conduct staff interviews and retraining during the site visit represents an incomplete remediation of the identified procedural issues.Implementation of strict adherence to manufacturer protocols and continuous patient monitoring requirements is essential for preventing similar incidents, and completion of staff retraining remains pending.
Event or Problem Description
Patient experienced a generalized tonic-clonic seizure during treatment sessions #18.Patient's right arm stiffen, followed by the patient slumping to the right side and exhibiting full-body shaking consistent with generalized convulsive activity.Patient remained unresponsive for approximately one minute following cessation of convulsive movements.Post-ictal confusion persisted for approximately five to six minutes.No significant injuries were sustained during the event, though a possible minor tongue bite was noted without associated bleeding.Importantly, no urinary or bowel incontinence occurred during or after the seizure.Patient was transported to the emergency department for evaluation and was subsequently discharged home the same day.

• Brand Name: BRAINSWAY DEEP TMS SYSTEM
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATION DEVICE
• 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: ahava stein ; 16 hartom str.; har hotzvim; jerusalem, 90777-516 ; IS 90777516
• MDR Report Key: 22175220
• Report Number: 3010300912-2025-19110
• Device Sequence Number: 7829576
• Product Code: OBP
• UDI-Device Identifier: 07290110538026
• UDI-Public: (01)07290110538026(11)210303
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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: DICYCLOMINE.; LATUDA 80 MG QHS; LUNESTRA 3 MG PRN; VYVANSE 40 MG QAM; ZOLOFT 100 MG 2 QDAY
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Sex: Female