UNKNOWN STIMULATORS

Description of Event or Problem

IT WAS REPORTED IN AN ARTICLE (NEVILLE, I.S., HAYASHI, C.Y., RODRIGUES, P., GALHARDONI, R.R.G., SOUSA-JUNIOR, L.M., RIOS, R.M., GUIRADO, V.M., ZANINOTTO, A.L., NAGUMO, M.M., AMORIM, R.O., BRUNONI, A.R., DE ANDRADE, D.C.,TEIXEIRA, M.J., PAIVA , W.S. HIGH-FREQUENCY RTMS FOR TRAUMATIC BRAIN INJURY: TOLERABILITY AND SAFETY CONSIDERATIONS (10743). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 188.) THAT ON A TOTAL OF 110 SESSIONS FOR THE ACG, MILD HEADACHE AFTER RTMS WAS REPORTED ON 9 SESSIONS WHILE DURING RTMS IT WAS ONLY REPORTED ON 4 SESSIONS; TENDERNESS OVER THE STIMULATION SITE ON 9 SESSIONS; HEARING DISCOMFORT ON 1; TEARING OF THE LEFT EYE ON 1; AND MILD DIZZINESS POST-TMS ON 2. FOR SG, OUT OF 110 SESSION, MILD HEADACHE WAS REPORTED ON 6 AND MODERATE HEADACHE ON 2, ALTHOUGH PATIENTS ALREADY HAD THIS SYMPTOM BEFORE THE PROTOCOL HAD STARTED. NO SEIZURES WERE EXPERIENCED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).