NEUROSTAR ADVANCED THERAPY
Received Feb 3, 2026 · Event occurred Jan 5, 2026
Report 3004824012-2026-00003 · MDR key 24251666
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
18 YR · Female
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
PATIENT HAD DISCOMFORT IN THEIR TEETH, SO THE COIL WAS ADJUSTED PER THE NEUROSTAR TRAINING GUIDE, BUT THEN THE PATIENT HAD A SLIGHT TWITCHING IN THEIR HAND. THE RECOMMENDED ADJUSTMENTS IN THE TRAINING GUIDE FOR HAND MOVEMENT WERE NOT MADE. THE PATIENT EXPERIENCED A SEIZURE ABOUT A MINUTE AFTER THE COIL HAD BEEN ADJUSTED (9 MINUTES 11 SECONDS (1850 PULSES) INTO THEIR FIRST TREATMENT). THE PATIENT HAS RECOVERED FROM THE SEIZURE BUT WILL NOT BE CONTINUING TMS TREATMENT. PATIENT DOES NOT HAVE A HISTORY OF SEIZURES.
Description of Event or Problem
THE TREATING PRACTICE CONTACTED NEURONETICS TO INFORM THEM THAT A PATIENT EXPERIENCED A SEIZURE DURING TMS.