NEUROSTAR ADVANCED THERAPY
Received Jul 18, 2023 · Event occurred Jun 20, 2023
Report 3004824012-2023-00015 · MDR key 17346618
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY 3.0Catalog number
81-02315-000
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
50 YR · Male
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
PATIENT EXPERIENCED A SEIZURE THAT LASTED APPROXIMATELY 15-30 SECONDS DURING TMS TREATMENT, AND AN AMBULANCE WAS CALLED. PATIENT REFUSED TO TAKE A DRUG TEST AT THE HOSPITAL. PATIENT RECOVERED WITHOUT ISSUE AND IS PLANNING TO CONTINUE WITH TMS TREATMENT. PATIENT HAS HAD A PRIOR HISTORY OF SUBSTANCE USE AND REPORTEDLY HAD TESTED POSITIVE FOR ILLICIT SUBSTANCES IN RECENT WEEKS WHICH COULD HAVE CONTRIBUTED TO LOWERING THE SEIZURE THRESHOLD. PATIENT REPORTEDLY RAN OUT OF TRAZADONE SEVERAL DAYS BEFORE SEIZURE AND HAD BEEN TAKING IT INCONSISTENTLY DURING TREATMENT WHICH COULD HAVE LOWERED THE PATIENT'S SEIZURE THRESHOLD.
Description of Event or Problem
NEURONETICS RECEIVED A CALL FROM A TMS PROVIDER WHICH REPORTED THAT ONE OF THEIR PATIENTS HAD EXPERIENCED A SEIZURE DURING THEIR 14TH TREATMENT SESSION, AND AN AMBULANCE WAS CALLED.