NEUROSTAR ADVANCED THERAPY

Description of Event or Problem

WHILE CONDUCTING A LITERATURE REVIEW, NEURONETICS CAME ACROSS A CASE REPORT FROM 2011 OF A PATIENT WHO RECEIVED 11 TOTAL TREATMENTS ON A NEUROSTAR AND DEVELOPED A POSTERIOR VITREOUS DETACHMENT AND RETINAL TEAR.

Additional Manufacturer Narrative

NUERONETICS WAS CONDUCTING A LITERATURE REVIEW AND FOUND THE FOLLOWING CASE REPORT: KUNG S, AHUJA Y, IEZZI R, SAMPSON SM. POSTERIOR VITREOUS DETACHMENT AND RETINAL TEAR AFTER REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION. BRAIN STIMUL. 2011;4(4):218-221. DOI:10.1016/J.BRS.2011.08.007. IN THIS REPORT, THE PATIENT RECEIVED A TOTAL OF 10 TREATMENTS FOR DEPRESSION USING AN OFF-LABEL PROTOCOL, WHERE SHE EXPERIENCED "TOLERABLE RIGHT EYE TWITCHING AND DISCOMFORT." PER THE OFFICE'S STANDARD PRACTICE, THE PATIENT'S MOTOR THRESHOLD WAS REMAPPED BEFORE HER 11TH TREATMENT. DURING THAT TREATMENT, SHE EXPERIENCED MORE RIGHT EYE TWITCHING AND DISCOMFORT AND, POST-TREATMENT DEVELOPED FLOATERS IN HER RIGHT EYE. THE PATIENT WENT TO THE OPHTHALMOLOGIST AND WAS DIAGNOSED WITH A POSTERIOR VITREOUS DETACHMENT AND RETINAL TEAR. FOLLOWING CORRECTIVE SURGERY FOR THE RETINAL TEAR, THE PATIENT RECEIVED ANOTHER 3 TMS TREATMENTS BEFORE TMS WAS DISCONTINUED AT THE RECOMMENDATION OF THE OPHTHALMOLOGIST DUE TO PATIENT EXPERIENCING "BLACK DOTS" IN HER RIGHT EYE. ALTHOUGH NEURONETICS CANNOT DEFINITIVELY DETERMINE IF THE TMS TREATMENT CONTRIBUTED TO THE EVENT, THIS CASE REPORT IS BEING DOCUMENTED AND SUBMITTED TO THE FDA OUT OF AN ABUNDANCE OF CAUTION.