inforMED
InjuryOBP

NEUROSTAR ADVANCED THERAPY SYSTEM

Received Sep 9, 2025

Report 3004824012-2025-00050 · MDR key 23008581

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Product problems

  • Patient-Device Incompatibility
  • Patient-Device Incompatibility

Patient

NA · Unknown

  • Suicidal Ideation
  • Suicidal Ideation

Narrative

Additional Manufacturer Narrative

NEURONETICS' SOCIAL MEDIA MONITOR REACHED OUT TO THE PERSON WHO POSTED THE ALLEGED ADVERSE EVENT. HOWEVER THE PERSON DID NOT RESPOND TO THE REQUEST AND THEREFORE A THOROUGH INVESTIGATION COULD NOT BE CONDUCTED. NEURONETICS COULD NOT CONFIRM THE PERSON WAS TREATED WITH NEUROSTAR BUT IS REPORTING OUT OF AN ABUNDANCE OF CAUTION DUE TO THE SERIOUS NATURE OF THE ALLEGATION.

Description of Event or Problem

NEURONETICS RECEIVED A NEGATIVE SOCIAL MEDIA POST ALLEGING TMS MAY HAVE "MADE ME WORSE, CAN'T STOP SUICIDAL THOUGHTS".