UNKNOWN RTMS STIMULATOR

Description of Event or Problem

IT WAS REPORTED IN AN ARTICLE (NEVILLE, I.S., HAYASHI, C.Y., SOUSA JUNIOR, L.M., GALHARDONI, R.R.G., MORAES, T.M., RODRIGUES, P., AMORIM, R.O., DE ANDRADE, D.C., ZANINOTTO, A.L., NAGUMO, M.M., BRUNONI, A.R., PAIVA, W.S. APPLICATION OF RTMS ON VICTIMS OF BIFRONTAL CEREBRAL CONTUSIONS. (10746). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 189.) THAT THERE WERE ABNORMALITIES ON BASELINE NEUROPSYCHOLOGICAL ASSESSMENT AND CORTICAL EXCITABILITY EVALUATION. DESPITE THE IMPROVEMENT OF SOME COGNITIVE ASPECTS ON THE EARLY EVALUATION AFTER RTMS, THIS PATTERN WAS NOT SUSTAINED 3 MONTHS LATER. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).