NEUROSTAR

Description of Event or Problem

NEURONETICS' SOCIAL MEDIA MONITOR FORWARDED A POST ALLEGING TMS TREATMENT CAUSED SEVERE MIGRAINES AND NAUSEA.

Additional Manufacturer Narrative

SINCE THE REPORTER DID NOT RESPOND TO NEURONETICS' ATTEMPTED OUTREACH FOR ADDITIONAL INFORMATION, IT WAS IMPOSSIBLE TO CONDUCT A THOROUGH INVESTIGATION AND CONFIRM THAT THE PERSON WAS TREATED WITH A NEUROSTAR DEVICE. BASED ON THE INFORMATION PROVIDED NO CAUSE CAN BE ATTRIBUTED BUT REPORTING OUT OF AN ABUNDANCE OF CAUTION. NOTE - THIS WAS ORIGINALLY ATTEMPTED TO BE SUBMITTED ON 5/20/25 BUT WAS FOUND TO HAVE NOT SUCCESSFULLY BEEN TRANSMITTED FROM ESUBMITTER. IT IS NOW BEING RESUBMITTED ON 7/16/25 AFTER RECEIVING GUIDANCE FROM FDA ESG/MDR TEAM AND RENUMBERING THE MDR (INITIALLY 3004824012-2025-00017).