NEUROSTAR ADVANCED THERAPY
Received Nov 20, 2024 · Event occurred Nov 8, 2024
Report 3004824012-2024-00029 · MDR key 20738302
Device
Generic name
Transcranial Magnetic Stimulation
Manufacturer
Neuronetics, Inc.Model number
VERSION 3.0Catalog number
81-02315-000
Lot number
NA
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
40 YR · Female
- Atrial Fibrillation
- Convulsion/Seizure
- Atrial Fibrillation
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
SEIZURE IS A RARE BUT SERIOUS KNOWN RISK OF TMS. HOWEVER A CAUSE FOR THE ATRIAL FIBRILATION (AF) IS UNKNOWN. AF IS NOT AN ESTABLISHED ADVERSE EVENT OF TMS.
Description of Event or Problem
A PRACTICE CALLED NEURONETICS TO REPORT THAT A PATIENT HAD A TONIC CLONIC SEIZURE DURING HER FIRST TREATMENT SESSION. THE PATIENT WAS TAKEN TO THE ER AND EXPERIENCED ATRIAL FIBRILLATION WHILE THERE. THE PATIENT WAS UNAWARE OF ANY CARDIAC ISSUES PRIOR TO THIS EVENT. THE PATIENT WILL NOT CONTINUE WITH TMS TREATMENT.