inforMED
InjuryOBP

NEUROSTAR ADVANCED THERAPY SYSTEM

Received Sep 16, 2025

Report 3004824012-2025-00056 · MDR key 23068849

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Product problems

  • Patient-Device Incompatibility
  • Patient-Device Incompatibility

Patient

NA · Male

  • Emotional Changes
  • Emotional Changes

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 TO CONFIRM THE ALLEGATIONS. NEURONETICS IS REPORTING OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem

NEURONETICS RECEIVED A NEGATIVE SOCIAL MEDIA POST ALLEGING TMS CAUSED HIM TO "SELF-HARM" AND TO GO INTO "FULL PSYCHOSIS".