DEEP TRANSCRANIAL MAGNETIC STIMULATOR
Received Jun 21, 2026 · Event occurred May 19, 2026
Report 3010300912-2026-24722 · MDR key 25571926
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Brainsway Ltd.Model number
104Catalog number
SYS-104-001
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Convulsion, Clonic
Narrative
Additional Manufacturer Narrative
KNOWN AND ANTICIPATED ADVERSE EVENT OF TMS.
Description of Event or Problem
APPROXIMATELY THREE MINUTES INTO THE 23RD TREATMENT USING THE BRAINSWAY H1 TREATMENT (THETA-BURST 600 PULSE PROTOCOL), THE PATIENT BEGAN TO HAVE CONTRACTIONS OF HER RIGHT HAND WHICH STEADILY PROGRESSED UP TO THE ARM IN A JACKSONIAN MANNER. THE PATIENT ALERTED THE TECHNICIAN THAT THEIR HAND WAS CRAMPING. THE TECHNICIAN STOPPED THE MACHINE, MOVED THE PATIENT TO THE FLOOR, NOTIFIED EMS AND THE NURSE PRACTITIONER. THE PATIENT BEGAN TO HAVE A GENERALIZED TONIC-CLONIC SEIZURE WHICH LASTED 1.5 MINUTES FOLLOWED BY A 5-7 MINUTE POSTICTAL PERIOD. THE PATIENT WAS TRANSPORTED TO A LOCAL EMERGENCY ROOM. A CT SCAN SHOWED NO REMARKABLE FINDINGS. THIS APPEARS TO HAVE BEEN A SEIZURE WITH NO KNOWN PRECIPITATING FACTORS.