NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

NEURONETICS RECEIVED A REPORTED MEDICAL EVENT FROM JAPAN REGARDING A PATIENT WHO EXPERIENCED A SUBARACHNOID HEMORRHAGE DURING A TREATMENT COURSE OF TMS. OVER THE COURSE OF THE WEEK PRIOR TO THE EVENT, THE PATIENT EXPERIENCED COMPLAINTS OF HEADACHE, SWEATING, CHEST DISCOMFORT, AND HEART PALPITATIONS. DOCTORS EVALUATED THE PATIENT WHEN HE REPORTED THESE EVENTS AND DID NOT FIND ANYTHING OF CONCERN. THE PATIENT RECEIVED 3 TREATMENTS DURING THE WEEK PRIOR TO THE EVENT. ON THE DAY BEFORE THE EVENT OCCURRED, PATIENT HAD A FEVER AND DID NOT RECEIVE HIS SCHEDULED TREATMENT THAT DAY. ON THE DAY OF THE EVENT, PATIENT REPORTEDLY COLLAPSED DUE TO A SUBARACHNOID HEMORRHAGE AND WAS SUBSEQUENTLY HOSPITALIZED. GIVEN THE PRESENT INFORMATION, NEURONETICS CANNOT CONCLUDE THAT TMS CONTRIBUTED TO THE EVENT. SUBARACHNOID HEMORRHAGES ARE NOT A KNOWN ADVERSE EVENT OF TMS AND TO OUR KNOWLEDGE HAS NOT BEEN REPORTED WITHIN LITERATURE. NEURONETICS IS REPORTING OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem

TEIJIN PHARMA, NEURONETICS' JAPANESE DISTRIBUTOR, REPORTED THAT A PATIENT EXPERIENCED A SUBARACHNOID HEMORRHAGE SEVERAL DAYS AFTER RECEIVING A TOTAL OF 27 TMS TREATMENTS.