NEUROSTAR ADVANCED THERAPY
Received Apr 26, 2023 · Event occurred Mar 16, 2023
Report 3004824012-2023-00010 · MDR key 16820206
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
18 YR · Male
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION, REGARDING THE PATIENT'S RISK FACTORS FOR SEIZURES (E.G., PRIOR OR FAMILY HISTORY OF SEIZURES, DEHYDRATION, LACK OF SLEEP, ALCOHOL, CAFFEINE, OR ILLICIT DRUG USE), WAS NOT ABLE TO BE OBTAINED SINCE NEITHER THE PATIENT OR THE PATIENT'S MOTHER WILL RESPOND TO THE PROVIDER'S OUTREACH FOR INFORMATION. THEREFORE, A DEFINITIVE CAUSE CANNOT BE ESTABLISHED.
Description of Event or Problem
NEURONETICS RECEIVED A CALL FROM A TMS PROVIDER INDICATING THAT A PATIENT HAD A SEIZURE THE MORNING AFTER THEIR 12TH TMS TREATMENT.