NEUROSTAR ADVANCED THERAPY
Received Mar 19, 2026 · Event occurred Feb 19, 2026
Report 3004824012-2026-00010 · MDR key 24642756
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR · Female
- Emotional Changes
Narrative
Additional Manufacturer Narrative
NO OTHER EXPLANATION WAS PROVIDED FOR THE MANIC STATE. ALL THE PATIENT'S MEDICATIONS WERE STOPPED AS WELL AS THE TMS TREATMENTS WHEN THE MANIC STATE OCCURRED. THE PATIENT'S SYMPTOMS IMPROVED, AND THEY WERE TRANSFERRED BACK TO THE REFERRING FACILITY. ACCORDING TO THE OUTPATIENT STAFF, IT DID NOT APPEAR THAT ANY TREATMENT WAS PROVIDED TO ADDRESS THE MANIC STATE. THE PATIENT'S SYMPTOMS IMPROVED AFTER STOPPING TREATMENT AND ALL MEDICATIONS, SO A CAUSAL RELATIONSHIP CANNOT BE RULED OUT. THE NEUROSTAR INSTRUCTIONS FOR USE (IFU) INCLUDES A WARNING FOR "SCREENING FOR BIPOLAR DISORDER" WHICH INDICATES THAT DEPRESSION MAY BE THE INITIAL PRESENTATION OF BIPOLAR DISORDER; ...PRIOR TO INITIATING ANTIDEPRESSANT TREATMENT, PATIENTS WITH DEPRESSIVE SYMPTOMS SHOULD BE ADEQUATELY SCREENED TO DETERMINE IF THEY HAVE BIPOLAR DISORDER; ...NEUROSTAR IS NOT CURRENTLY CLEARED OR APPROVED FOR USE IN TREATING BIPOLAR DEPRESSION.
Description of Event or Problem
AT THE 8TH TMS TREATMENT SESSION, THE PATIENT SHOWED A TENDENCY TOWARD A MANIC STATE.