inforMED
InjuryOBP

NEUROSTAR ADVANCED THERAPY

Received Jan 12, 2026 · Event occurred Dec 17, 2025

Report 3004824012-2026-00002 · MDR key 24038320

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc

Model number

V.3.0

Catalog number

81-01335-000

Product problems

  • Patient-Device Incompatibility

Patient

28 YR · Female

  • Headache

Narrative

Additional Manufacturer Narrative

PATIENT REPORTED HAVING 70 MIGRAINES PER MONTH COMPARED TO 2-3 PER MONTH PRIOR TO TMS. THE PATIENT SOUGHT CARE AT THE ER DUE TO THE MIGRAINES AND HAS BEEN GIVEN AN ANTI-CONVULSANT MEDICATION WHICH SEEMS TO BE HELPING MORE THAN ANYTHING ELSE YET. HOWEVER, THE PATIENT DID NOT HAVE ANY COMPLAINTS DURING TREATMENT OR FOR THE PAST 6 MONTHS. WHENEVER THE PRACTICE HAS SPOKEN WITH THE PATIENT (SINCE SHE CALLED WITH THE COMPLAINT), THE PATIENT HAS A POSITIVE HAPPY AFFECT (MOOD) WHEN SPEAKING TO HER. THIS DOESN'T MATCH WHAT SHE IS TELLING THEM. THE PATIENT WAS OPEN WITH THE TREATER DURING HER COURSE OF TREATMENT THAT SHE WAS CONSTANTLY SEARCHING THE INTERNET FOR SIDE EFFECTS FROM TMS AND TENDS TO HAVE ATTENTION SEEKING BEHAVIORS. THE PATIENT ALLEGES THAT SHE LOST HER JOB DUE TO THE INCREASE IN MIGRAINES, HOWEVER, THE PATIENT HAS A HISTORY OF LOSING JOBS (REASONS UNKNOWN).

Description of Event or Problem

THE PATIENT NOTIFIED THE TMS PROVIDER'S OFFICE THAT THEY HAVE BEEN EXPERIENCING WORSENING MIGRAINES SINCE ENDING TMS TREATMENT 6 MONTHS AGO.