DEEP TMS SYSTEM
Received Apr 4, 2025 · Event occurred Mar 13, 2025
Report 3010300912-2025-18376 · MDR key 21771664
Device
Generic name
Transcranial Magnetic Stimulation (tms)
Manufacturer
Brainsway Ltd.Model number
104Catalog number
SYS-104-001
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
28 YR · Female
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
KNOWN AE OF TMS.
Description of Event or Problem
PATIENT EXPERIENCED A TONIC-CLONIC SEIZURE DURING TREATMENT SESSION #3, WITH LABORED BREATING AND ORAL SECRETIONS. SEIZURE WAS RESOLVED WITHIN 2 MINUTES. INITIALLY, PATIENT WAS LETHARGIC CONFUSED AND NOT ORIENTED, ALTHOUGH THE PATIENT'S SENSORIUM CLEARED AND PATIENT BECAME MORE ALERT AND CONVERSANT WITHIN A FEW MINUTES. PATIENT WAS SENT TO THE ER. CT AND BLOOD WORK WERE NORMAL. NO SEIZURE HISTORY OR FAMILY SEIZURE HISTORY AND NO SLEEP DEPRIVATION. THIS WAS PROBABLY A TMS-PROVOKED SEIZURE.