inforMED
InjuryOBP

NEUROSTAR ADVANCED THERAPY SYSTEM

Received Sep 9, 2025

Report 3004824012-2025-00051 · MDR key 23008584

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Product problems

  • Patient-Device Incompatibility
  • Patient-Device Incompatibility

Patient

NA · Unknown

  • Speech Disorder
  • Speech Disorder

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.

Description of Event or Problem

NEURONETICS RECEIVED A NEGATIVE SOCIAL MEDIA POST ALLEGING TMS HAD A NEGATIVE IMPACT ON THE PERSON'S PROGRESS MADE IN SPEECH THERAPY WHICH THEY HAD RECEIVED POST-STROKE AND PRIOR TO TMS TREATMENT.