NEUROSTAR ADVANCED THERAPY SYSTEM

Description of Event or Problem

TEIJIN PHARMA, NEURONETICS' JAPANESE DISTRIBUTOR, REPORTED THAT A RETINAL TEAR IN THE LEFT EYE OF A PATIENT WAS DISCOVERED DURING A MEDICAL EXAMINATION. PATIENT'S TREATMENT WAS DISCONTINUED AS A RESULT AND PATIENT UNDERWENT SURGERY TO CORRECT THE RETINAL TEAR.

Additional Manufacturer Narrative

NEURONETICS RECEIVED A MEDICAL EVENT FROM JAPAN INDICATING THAT A RETINAL TEAR IN THE LEFT EYE OF A PATIENT WAS DISCOVERED DURING A MEDICAL EXAMINATION. AS A RESULT, TREATMENT WAS DISCONTINUED AND PATIENT RECEIVED PHOTOCOAGULATION SURGERY TO CORRECT THE RETINAL TEAR. IT WAS NOTED THAT THE PATIENT RECEIVED A FUNDUS EXAMINATION PRIOR TO BEGINNING TMS AND DID NOT HAVE ANY ISSUES. NEURONETICS IS UNABLE TO INVESTIGATE THE COMPLAINT FURTHER AS IT WAS REPORTED TO NEURONETICS' DISTRIBUTOR IN JAPAN, TEIJIN PHARMA, AFTER THE TREATING PHYSICIAN WAS TRANSFERRED TO ANOTHER FACILITY.