DEEP TMS SYSTEM
Received Mar 6, 2025 · Event occurred Feb 13, 2025
Report 3010300912-2025-17926 · MDR key 21536008
Device
Generic name
Transcranial Magnetic Stimulation (tms)
Manufacturer
Brainsway Ltd.Model number
104Catalog number
SYS-104-001
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
32 YR · Male
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
KNOWN AE OF TMS.
Description of Event or Problem
PATIENT EXPERIENCED A GENEREALIZED TONIC CLONIC SEIZURE MIDWAY THROUGH TREATMENT NUMBER 29 (DURING TRAIN 28). WITHIN 1 MINUTE THE SEIZURE WAS RESOLVED AND THE PATIENT HAD POST ICTAL CONFUSION BUT WAS ALERT AND ORIENTED WITHIN 5 MIN AND COULD AMBULATE. HE WAS TAKEN TO THE ER AND RELEASED BY THE EMERGENCY ROOM TEAM. NO SEIZURE HISTORY OR FAMILY SEIZURE HISTORY, NO SLEEP DEPRIVATION, NO CHANGE IN MEDICATIONS OR HEALTH CONDITION AND NO ALCOHOL OR SUBSTANCE CONSUMPTION.