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

NEURONETICS RECEIVED INFORMATION FROM A PRACTICE THAT A PATIENT WAS EXPERIENCING WORSENING TINNITUS AFTER STARTING TMS TREATMENT.