inforMED
InjuryOBP

NEUROSTAR ADVANCED THERAPY SYSTEM

Received Sep 16, 2025 · Event occurred Aug 12, 2025

Report 3004824012-2025-00055 · MDR key 23068892

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Model number

NEUROSTAR 3.8

Catalog number

81-05315-000

Product problems

  • Patient-Device Incompatibility
  • Patient-Device Incompatibility

Patient

26 YR · Female

  • Headache
  • Headache

Narrative

Description of Event or Problem

NEURONETICS RECEIVED INFORMATION FROM A PRACTICE REGARDING A PATIENT THAT STARTED HAVING PERSISTENT MIGRAINES AFTER TMS TREATMENT NUMBER 17, THE PATIENT WENT TO THE ER TWICE DUE TO THE MIGRAINES BUT THEY WERE UNABLE TO DETERMINE THE CAUSE OR RULE OUT TMS AS THE CAUSE AND REFERRED HER TO A NEUROLOGIST. THE PATIENT REPORTS NOT BEING ABLE TO WORK AS A RESULT OF THE MIGRAINES.

Additional Manufacturer Narrative

DURING THE PATIENT'S ER VISITS, THEY COULD NOT RULE OUT TMS AS A CAUSE FOR HER MIGRAINES, HOWEVER THE PATIENT HAS CONTINUED TMS TREATMENT SINCE HER DEPRESSION HAS IMPROVED.