NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

NEURONETICS RECEIVED A MEDWATCH FROM THE FDA IN WHICH A PATIENT ALLEGES THE ABOVE REPORTED ADVERSE EVENTS. THE PATIENT NOTED IN THE MEDWATCH THAT THEY WERE TREATED WITH A "NOVASTAR" DEVICE HOWEVER NO CONTACT INFORMATION WAS PROVIDED TO CONDUCT A THOROUGH INVESTIGATION AND THEREFORE NEURONETICS CANNOT CONFIRM THE DETAILS OF THE ALLEGED EVENTS OR CONFIRM THAT A NEUROSTAR DEVICE WAS USED TO TREAT THE PATIENT.

Description of Event or Problem

NEURONETICS RECEIVED A MEDWATCH FROM THE FDA IN WHICH A PATIENT ALLEGES THAT WHILE RECEIVING TMS THEY EXPERIENCING WORSENING DEPRESSION, WAS HOSPITALIZED FOLLOWING TREATMENT, EXPERIENCED WORSENING ANXIETY, AND CANNOT FEEL EMOTION.