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 ALTHOUGH THEY DID PROVIDE THE NAME OF THE PRACTICE WHERE HE WAS TREATED. NEURONETICS CONFIRMED THE PRACTICE WAS A NEUROSTAR PROVIDER AND THAT HE WAS TREATED IN (B)(6) 2014. THE PROVIDER STATED THAT THE PATIENT DIDN'T MENTION THE LOSS OF SMELL UNTIL (B)(6) 2015, 5 MONTHS AFTER TMS TREATMENT. THE PROVIDER ALSO NOTED THAT THE PATIENT WAS BEING WEANED OFF OF CYMBALTA DURING THIS TIME. THERE ARE REPORTED SIDE EFFECTS WITH CYMBALTA AND SMELL IMPAIRMENT. LOSS OF SENSE SMELL IS NOT A KNOWN SIDE EFFECT OF TMS BUT 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 THAT TMS TREATMENT CAUSED ANOSMIA (SENSE OF SMELL LOSS).