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

Model Number 102

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Convulsion/Seizure (4406)

Event Date 10/06/2023

Event Type  Injury  

Manufacturer Narrative

Tms provoked seizure.Patient should avoid further high frequency tms.

Event Description

Tms provoked seizure.Right arm lifted up over face, head turned, began shaking, slid down in chair, operator turned off machine, and kept patient upright.Seizure lasted approximately 45 seconds.Postictal, unable to talk or move for 30 minutes.Taken by ems to hospital.Head ct and labs showed no abnormal findings.

• Brand Name: DEEP TMS SYSTEM
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION (TMS)
• Manufacturer (Section D): BRAINSWAY LTD.; 19 hartom str.; jerusalem, 91451 ; IS 91451
• Manufacturer (Section G): BRAINSWAY LTD.; 19 hartom str.; jerusalem, 91451 ; IS 91451
• Manufacturer Contact: ahava stein ; 19 hartom str.; jerusalem, 91451 ; IS 91451
• MDR Report Key: 18919089
• MDR Text Key: 337844427
• Report Number: 3010300912-2023-12345
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K122288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102
• Device Catalogue Number: MAG-102-001
• Device Lot Number: GR19000308
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EFFEXOR XR 187.5; MELATONIN; OMEPRAZOLE; PRAVASTATIN; TRAZADONE; ZYRTEC
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female