NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

THE MEDWATCH REPORTER DID NOT SHARE THEIR NAME OR CONTACT INFORMATION AND THEREFORE NEURONETICS WAS UNABLE TO CONFIRM THAT A NEUROSTAR DEVICE WAS USED TO TREAT THE PATIENT. FURTHERMORE, WITHOUT INFORMATION FROM THE PATIENT AND/OR PROVIDER, IMPORTANT DATA RELATED TO COMORBIDITIES AND CONCOMITANT MEDICATION WAS UNAVAILABLE TO FULLY INVESTIGATE THE ALLEGED EVENTS. WITHIN THE REPORT, THE PATIENT MENTIONS SHE HAS A HISTORY OF MIGRAINES, AND HER PROVIDER BELIEVES THAT THESE EVENTS MAY BE DUE TO PTSD. THE PATIENT REPORTEDLY EXPERIENCED HER "RIGHT LEG JUMPING OFF THE CHAIR" DURING TREATMENT WITH "EACH PULSE". IF THE PATIENT WAS TREATED WITH A NEUROSTAR DEVICE, THE EVENT OF "LEG JUMPING" DUE TO PULSES WOULD BE UNLIKELY UNLESS THE COIL WAS POSITIONED IN AN INCORRECT AREA FOR TREATMENT IF THE PATIENT WAS BEING TREATED FOR MDD.

Description of Event or Problem

NEUROENTICS RECEIVED A MEDWATCH FROM A PATIENT REPORTEDLY CLAIMING TO HAVE EXPERIENCED MULTIPLE ADVERSE EVENTS OVER THE COURSE OF 3 TMS TREATMENTS. PATIENT REPORTEDLY EXPERIENCED: MIGRAINES WITH TINNITUS, SEVERE FATIGUE, PROBLEMS WITH SLEEP, LEG "JUMPING" IN RESPONSE TO STIMULATION, INCREASED ANXIETY, CONFUSION, DISSOCIATION, PANIC, TOOTH SENSITIVITY, SUICIDAL IDEATION, AND NAUSEA/LOSS OF APETITE.