NEUROSTAR ADVANCED THERAPY
Received Mar 4, 2026 · Event occurred Feb 4, 2026
Report 3004824012-2026-00009 · MDR key 24508314
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Female
- Emotional Changes
Narrative
Description of Event or Problem
PATIENT IN A JAPAN HOSPITAL, WHO WAS RECEIVING NEUROSTAR TMS TREATMENT, BEGAN EXPERIENCING A MANIC STATE OR SHOWING THE TENDENCY TO BE IN A MANIC STATE. THE PATIENT WAS USING "PRESSURED" SPEECH, SHOWING EXCESSIVE INVOLVEMENT WITH OTHER PATIENTS, AND SHOWING IRRITABILITY.
Additional Manufacturer Narrative
TMS THERAPY WAS STOPPED ON (B)(6) 2026 AND PHARMACOTHERAPY WAS INITIATED WITH ANTIDEPRESSANT/PSYCHOTROPIC AGENTS (ARIPRPRAZOLE AND VALPROATE) WHICH THE PATIENT WAS NOT ON DURING THE EVENT. AFTER SEVERAL DAYS, THE MANIC SYMPTOMS HAVE GRADUALLY BEGUN TO SUBSIDE. THE PATIENT DID NOT HAVE A HISTORY OF MANIA EPISODES. THE UNIT INVOLVED IS SPECIFIC FOR THE JAPAN MARKETPLACE ONLY BUT IS SIMILAR TO A VERSION SOLD IN THE USA.