inforMED
InjuryOBP

NEUROSTAR

Received May 16, 2025

Report 3004824012-2025-00014 · MDR key 22036657

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Product problems

  • Patient-Device Incompatibility
  • Patient-Device Incompatibility

Patient

NA · Unknown

  • Suicidal Ideation
  • Suicidal Ideation

Narrative

Description of Event or Problem

NEURONETICS' SOCIAL MEDIA MONITOR FORWARDED A POST ALLEGING TMS TREATMENT LEAD TO SUICIDALITY.

Additional Manufacturer Narrative

SINCE THE REPORTER DID NOT RESPOND TO NEURONETICS' ATTEMPTED OUTREACH FOR ADDITIONAL INFORMATION, IT WAS IMPOSSIBLE TO CONDUCT A THOROUGH INVESTIGATION AND CONFIRM THAT THE PERSON WAS TREATED WITH A NEUROSTAR DEVICE. IN THE POST THE PATIENT MENTIONED HAVING BIPOLAR DISORDER WHICH IS A CONTRAINDICATION FOR TMS. BASED ON THE INFORMATION PROVIDED NO CAUSE CAN BE ATTRIBUTED BUT REPORTING OUT OF AN ABUNDANCE OF CAUTION.