NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

NEURONETICS RECEIVED A CALL FROM A PROVIDER'S OFFICE REPORTING ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE ABOUT 4 MINUTES INTO HER 9TH TREATMENT SESSION. PATIENT INITIALLY BEGAN TO EXPERIENCE RIGHT ARM TWITCHING WHEN TREATMENT BEGAN. TREATMENT WAS PAUSED TO ADJUST THE COIL IN AN ATTEMPT TO ALLEVIATE THE TWITCHING. WHEN TREATMENT RESUMED, THE PATIENT STATED THAT THE ARM TWITCH HAD STARTED TO BECOME PAINFUL. TREATMENT WAS PAUSED AGAIN TO MAKE FURTHER ADJUSTMENTS. AS THE SESSION WAS PAUSED, THE PATIENT BEGAN TO SEIZE AND BECOME STIFF. THE PATIENT WAS REPORTEDLY UNRESPONSIVE FOR ABOUT 90 SECONDS. ONCE THE PATIENT BECAME VERBALLY RESPONSIVE, THE PROVIDER CALLED EMS AND PATIENT WAS TAKEN TO THE ER. PATIENT HAS SINCE EXPRESSED THAT SHE WOULD LIKE TO CONTINUE WITH TMS SINCE THE EVENT BUT WILL BE EVALUATED BY A NEUROLOGIST PRIOR TO A DECISION BEING MADE ON WHETHER TO CONTINUE WITH TREATMENT. THE PATIENT IS ON SEVERAL MEDICATIONS THAT COULD IMPACT HER SEIZURE THRESHOLD INCLUDING WELLBUTRIN, TRINTELLIX, AND KLONOPIN WHICH COULD HAVE CONTRIBUTED TO THE EVENT.

Description of Event or Problem

NEURONETICS RECEIVED A CALL FROM A TREATER REPORTING THAT ONE OF THEIR PATIENTS HAD EXPERIENCED A SEIZURE DURING HER 9TH TREATMENT. THE OFFICE CONTACTED EMS AND THE PATIENT WAS THEN TAKEN TO THE ER.