NEUROSTAR ADVANCED THERAPY SYSTEM

Additional Manufacturer Narrative

NEURONETICS WAS CONTACTED BY A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS BECAME NAUSEOUS DURING HIS FIRST TREATMENT SESSION AND TREATMENT WAS PAUSED. THE PATIENT BEGAN BURPING BEFORE PASSING OUT. PATIENT REPORTEDLY EXPERIENCED A BRIEF PERIOD OF SHAKING BEFORE QUICKLY "FALLING ASLEEP". THE PROVIDER ASSESSED THE PATIENT AND CONCLUDED THAT PATIENT MOST LIKELY EXPERIENCED A VASOVAGAL RESPONSE BUT SENT PATIENT TO THE EMERGENCY ROOM FOR FURTHER EVALUATION. PATIENT WAS NOTED TO HAVE A HISTORY OF SYNCOPAL EPISODES WITH THE MOST RECENT OCCURRING IN (B)(6) 2024. UPON INVESTIGATION, THE TREATMENT LOCATION THAT WAS USED SUGGESTS THAT THE COIL PLACEMENT MAY HAVE BEEN TOO CLOSE TO THE PATIENT'S MOTOR STRIP BASED ON THE PATIENT'S STATURE AND SIZE WHICH COULD HAVE RESULTED IN THE REPORTED ADVERSE EVENT. PATIENT WILL BE FOLLOWING UP WITH CARDIOLOGY FOR CLEARANCE TO RETURN TO TREATMENT AS THIS IS THE PATIENT'S SECOND SYNCOPAL EPISODE WITHIN A 3-MONTH PERIOD.

Description of Event or Problem

NEURONETICS WAS CONTACTED BY A PROVIDER THAT REPORTED ONE OF THEIR PATIENTS BECAME NAUSEOUS AND PROCEEDED TO PASS OUT DURING HIS FIRST TREATMENT SESSION. THE TREATER NOTED THAT WHILE THE PATIENT WAS PASSED OUT, HE EXPERIENCED A PERIOD OF "BRIEF SHAKING" BEFORE FALLING "INTO A DEEP SLEEP" AND BEGAN TO SNORE. PATIENT WAS SENT TO THE ER AS A PRECAUTION.