InjuryOBP
NEUROSTAR ADVANCED THERAPY SYSTEM
Received Mar 27, 2025 · Event occurred Mar 6, 2025
Report 3004824012-2025-00006 · MDR key 21711669
Device
Generic name
Transcranial Magnetic Stimulation
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR 3.6Catalog number
81-03315-000
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
26 YR · Female
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
PATIENT DOES NOT HAVE ANY SEQUELAE BUT DISCONTINUED TMS TREATMENT. PATIENT WAS TAKING MEDICATIONS WHICH MAY LOWER SEIZURE THRESHOLD AND, IN ADDITION TO TMS, MAY HAVE CONTRIBUTED TO THE INCIDENT.
Description of Event or Problem
NEURONETICS WAS MADE AWARE BY A TMS PRACTICE THAT A PATIENT EXPERIENCED RIGHT SIDE ARM AND LEG SHAKING AN HOUR AND A HALF FOLLOWING HER 25TH TMS TREATMENT. PATIENT WAS TAKEN TO THE ER AND CONFIRMED TO BE A SEIZURE.