NEUROSTAR ADVANCED THERAPY
Received Aug 3, 2023 · Event occurred Jul 6, 2023
Report 3004824012-2023-00016 · MDR key 17452988
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY V3.7.1Catalog number
81-02315-000
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
35 YR · Female
- Anxiety
- Anxiety
Narrative
Additional Manufacturer Narrative
TMS TREATER REPORTED THAT ONE OF THEIR PATIENTS WAS EXPERIENCING INCREASED ANXIETY AFTER RECEIVING 10 TREATMENTS. PATIENT RECEIVED 9 TREATMENTS OF STANDARD TMS TREATMENT AND 1 TREATMENT OF THETA BURST, AFTER WHICH PATIENT REPORTED INCREASED ANXIETY. PATIENT IS CURRENTLY ON HER SECOND COURSE OF TMS. PATIENT HAS BEEN EXPERIENCING "A LOT OF LIFE ISSUES" RECENTLY AND IS "REALLY OVERWHELMED". ACCORDING TO THE PROVIDER, THE PATIENT IS NOT AN ANY MEDICATIONS BUT PROVIDER PRESCRIBED PATIENT A BENZODIAZEPINE IN RESPONSE TO HER INCREASED ANXIETY, ALTHOUGH THE PATIENT ADMITTED TO NOT TAKING IT. PATIENT HAS CONTINUED WITH STANDARD TMS TREATMENT AND WAS ON HER 15TH SESSION OUT OF 36. BASED ON THE PROVIDED INFORMATION, IT CAN NOT BE RULED OUT WHETHER HER INCREASED ANXIETY WAS DUE TO THE THETA BURST SESSION, HER PERSONAL ISSUES, OR A COMBINATION OF THESE FACTORS.
Description of Event or Problem
NEURONETICS RECEIVED A CALL FROM A TMS PROVIDER WHICH REPORTED THAT ONE OF THEIR PATIENTS EXPERIENCING INCREASED ANXIETY WITH TREATMENT.