inforMED
InjuryOBP

NEUROSTAR

Received Jun 23, 2025

Report 3004824012-2025-00036 · MDR key 22311539

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Model number

UNK

Catalog number

UNK

Product problems

  • Appropriate Device Problem Term/Code Not Available
  • Appropriate Device Problem Term/Code Not Available

Patient

NA · Female

  • Emotional Changes
  • Emotional Changes

Narrative

Description of Event or Problem

NEURONETICS WAS MADE AWARE OF NEGATIVE COMMENTS, ON A NEUROSTAR POST, BY THE COMPANY'S SOCIAL MEDIA MONITOR INCLUDING ONE THAT ALLEGED THAT TMS TREATMENT DID NOT WORK AND SYMPTOMS GOT WORSE AS A RESULT OF TMS TREATMENT.

Additional Manufacturer Narrative

THE PERSON WHO POSTED THE ALLEGED ADVERSE EVENT DID NOT RESPOND TO A REQUEST TO CONTACT NEURONETICS' CUSTOMER SERVICE TO OBTAIN ADDITIONAL INFORMATION. NEURONETICS WAS NOT ABLE TO DO A THOROUGH INVESTIGATION DUE TO THE LIMITED INFORMATION. HOWEVER, NEURONETICS IS SUBMITTING OUT OF AN ABUNDANCE OF CAUTION GIVEN THE ALLEGATION OF A POTENTIAL SERIOUS ADVERSE EVENT.