NEUROSTAR

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.

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 THE PERSON'S HUSBAND GOT WORSE AS A RESULT OF TMS TREATMENT.