NEUROSTAR

Additional Manufacturer Narrative

THIS ADVERSE EVENT IS SUBMITTED TO THE AGENCY LATE AS A CORRECTIVE ACTION SINCE IT WAS DETERMINED TO BE REPORTABLE AFTER AN AUDIT OF THE COMPANY'S COMPLAINT DATABASE.

Description of Event or Problem

PT. EXPERIENCE HEAD PAIN AND EYELID DROOP AFTER 2ND TX. TREATING PHYSICIAN SENT PATIENT TO ER UPON ARRIVAL TO 3RD TX. PT. WAS SUBJECTED TO A CT SCAN (AND ASSOCIATED RISKS WHICH OTHERWISE MAY NOT HAVE REQUIRED). PT. DIAGNOSED WITH COMPLEX MIGRAINES. CAN NOT RULE OUT THAT TMS MAY HAVE CONTRIBUTED TO THE CONDITION AND REQUIREMENT OF DIAGNOSTIC TX. SUBMITTING OUT OF AN ABUNDANCE OF CAUTION.