InjuryOBP
DEEP TMS SYSTEM
Received Mar 17, 2024 · Event occurred Oct 6, 2023
Report 3010300912-2023-12345 · MDR key 18919089
Device
Generic name
Transcranial Magnetic Stimulation (tms)
Manufacturer
Brainsway Ltd.Model number
102Catalog number
MAG-102-001
Lot number
GR19000308
Product problems
- Defibrillation/Stimulation Problem
- Defibrillation/Stimulation Problem
Patient
65 YR · Female
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
TMS PROVOKED SEIZURE. PATIENT SHOULD AVOID FURTHER HIGH FREQUENCY TMS.
Description of Event or Problem
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.