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. PATIENT INFORMATION, BELIEVED TO BE THAT OF THE PERSON POSTING THE COMPLAINT (BASED ON NAME AND LOCATION), WAS FOUND IN THE TRAKSTAR DATABASE WHICH INCLUDED THE PROVIDER'S CONTACT DETAILS. THE PROVIDER DID NOT RETURN COMMUNICATION ATTEMPTS BY NEURONETICS FOR ADDITIONAL INFORMATION. THE TRAKSTAR DATABASE PRACTICE NOTES STATE THAT THE PATIENT DID NOT HAVE ANY SIDE EFFECTS DURING HER TREATMENT. BASED ON THE LIMITED INFORMATION, NO CONCLUSIONS CAN BE DRAWN BUT NEURONETICS IS SUBMITTING OUT OF AN ABUNDANCE OF CAUTION.

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 CAUSED (NONSPECIFIC) EYESIGHT ISSUES AND CHRONIC MIGRAINES.