NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

PROVIDER CONTACTED NEURONETICS REGARDING THEIR PATIENT WHO HAD EXPERIENCED HEADACHES, A "NEEDLE PRICKLING" SENSATION ON THE LEFT SIDE OF THEIR HEAD, AND RINGING IN THEIR EARS AFTER COMPLETING 3 TREATMENTS. ACCORDING TO THE PROVIDER, PATIENT HAD BEEN COMPLAINING ABOUT HEADACHES FOLLOWING TREATMENT AND HAD TO TAKE TYLENOL TO RELIEVE THEM. HEADACHES ARE A COMMON WELL KNOWN SIDE EFFECT OF TMS THAT ARE EXPECTED TO SUBSIDE AFTER THE FIRST WEEK OR SO OF RECEIVING TREATMENT. ACCORDING TO THE PROVIDER, THE PATIENT DID NOT INITIALLY WEAR EARPLUGS DURING TREATMENT. PATIENT HAS A PAST HISTORY OF TINNITUS BUT REPORTED THAT THIS INSTANCE WAS "WORSE" THAN IN THE PAST. PATIENT HAD STOPPED TMS AS A RESULT OF HER SYMPTOMS. UPON FURTHER FOLLOW UP WITH THE PROVIDER, ALL OF THE PATIENT'S SYMPTOMS HAD RESOLVED EXCEPT FOR THE TINNITUS WHICH HAS IMPROVED BUT HAS NOT FULLY RESOLVED. NEURONETICS IS REPORTING OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem

NEURONETICS WAS CONTACTED BY A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS HAD BEEN EXPERIENCING A HEADACHE, A "NEEDLE PRICKING" SENSATION ON THE LIFT SIDE OF THEIR HEAD, AND RINGING IN THE EARS AFTER TREATMENT AFTER ONLY RECEIVING 3 TREATMENTS.