NEUROSTAR ADVANCED THERAPY
Received Aug 3, 2023 · Event occurred Jul 5, 2023
Report 3004824012-2023-00018 · MDR key 17452965
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY V3.0Catalog number
81-02315-000
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
24 YR · Female
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
TMS PROVIDER REPORTED THAT ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE DURING HER 12TH TREATMENT AND WAS TAKEN TO THE ER. PATIENT'S TREATER REPORTEDLY NOTICED THAT THE COIL HAD MOVED SLIGHTLY DURING TREATMENT. TREATER PAUSED TREATMENT TO READJUST THE COIL AND WHEN THEY RESTARTED TREATMENT, THE PATIENT REPORTEDLY HAD A SEIZURE. PATIENT IS ON WELLBUTRIN AND HAS REPORTEDLY BEEN EXPERIENCING INCREASED LEVELS OF STRESS WHICH COULD HAVE AFFECTED THE PATIENT'S SEIZURE THRESHOLD.
Description of Event or Problem
NEURONETICS RECEIVED A CALL FROM TMS PROVIDER REPORTING THAT ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE DURING TREATMENT.