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 REVIEWED THE PERSON'S FACEBOOK PAGE AND IT APPEARS THAT THE PERSON LIVES IN (B)(6), CANADA. NEUROSTAR IS NOT APPROVED IN CANADA AND NEURONETICS DOES NOT DISTRIBUTE DEVICES OR ACCESSORIES THERE. IT IS VERY LIKELY THE PERSON WAS TREATED ON ANOTHER TMS DEVICE WHICH IS AVAILABLE IN CANADA. NEURONETICS IS SUBMITTING OUT OF AN ABUNDANCE OF CAUTION GIVEN THE SERIOUS ADVERSE EVENT ALLEGATION.

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 PATIENT HAD A HEMORRHAGIC STROKE AS A RESULT OF TMS TREATMENT.