inforMED
InjuryOBP

NEUROSTAR

Received Jul 22, 2025

Report 3004824012-2025-00041 · MDR key 22570614

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Model number

NEUROSTAR 3.0

Catalog number

81-02315-000

Product problems

  • Patient-Device Incompatibility
  • Patient-Device Incompatibility

Patient

56 YR · Female

  • Headache
  • Tinnitus
  • Headache
  • Tinnitus

Narrative

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE ON HOW TMS MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITIONS. TEST RESULTS DO NOT CORROBORATE ANY NEUROLOGICAL DAMAGE.

Description of Event or Problem

NEURONETICS RECEIVED AN EMAIL FROM A NEUROSTAR PATIENT THAT REPORTS RINGING IN HER EARS AND HEADACHES AFTER SEVERAL TMS TREATMENT SESSIONS.