NEUROSTAR ADVANCED THERAPY
Received Jan 17, 2024 · Event occurred Dec 19, 2023
Report 3004824012-2024-00003 · MDR key 18525091
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
19 YR · Male
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
NEURONETICS WAS CONTACTED BY A PROVIDER WHO REPORTED THAT ONE OF THEIR PATIENTS HAD EXPERIENCED A SEIZURE ABOUT 8 MINUTES INTO THEIR 2ND TREATMENT SESSION. PATIENT WAS MONITORED AT THE OFFICE AFTER THE SEIZURE OCCURRED AND LEFT THE OFFICE WITH HIS MOTHER. PER THE PROVIDER, PATIENT HAD RECENTLY STARTED BUPROPRION PRIOR TO BEGINNING TMS. BUPROPRION IS KNOWN TO POTENTIALLY LOWER THE SEIZURE THRESHOLD IN PATIENTS. FOLLOWING THE EVENT, THE PROVIDER DECIDED TO DISCONTINUE THE PATIENT'S BUPROPRION. THE PATIENT DID NOT CONTINUE TMS TREATMENT.
Description of Event or Problem
NEURONETICS WAS CONTACTED BY A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS HAD EXPERIENCED A SEIZURE DURING THEIR 2ND TREATMENT SESSION.