NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

NEURONETICS RECEIVED A CALL FROM A PROVIDER, INITIALLY ASKING FOR HELP REGARDING A PATIENT WHO WAS EXPERIENCING MOVEMENT IN HIS RIGHT HAND FOLLOWING THE 24TH TREATMENT SESSION. THE PROVIDER REPORTEDLY MADE ADJUSTMENTS TO THE TREATMENT COIL TO ADDRESS THE MOVEMENT AND PATIENT WAS GIVEN A SINGLE TRAIN (40 PULSES). THE PATIENT REPORTED THAT THIS WAS UNCOMFORTABLE AND HE FELT A "STINGING, SHARP PAIN IN A LINE FROM THE TOP OF HIS HEAD THROUGH HIS TEMPLE AND BEHIND HIS RIGHT EYE". THE PROVIDER RE-ADJUSTED THE COIL AGAIN BACK TO THE ORIGINAL POSITION AND THEN FINISHED THAT TREATMENT SESSION WITHOUT ANY ADDITIONAL COMPLAINT FROM THE PATIENT. THE NEXT DAY, THE PATIENT CALLED THE PROVIDER'S OFFICE COMPLAINING OF A HEADACHE THAT WOULD NOT GO AWAY, AND HE REPORTEDLY HAD TO GO TO URGENT CARE AS A RESULT. THE PROVIDER REPORTED THAT THE PATIENT WAS "VERY UPSET". NEURONETICS SPOKE WITH THE PATIENT WHO REITERATED THAT HE EXPERIENCED A "RIGHT SIDED" HEADACHE FOLLOWING TREATMENT, WENT TO URGENT CARE, AND WAS GIVE TORADOL, A PRESCRIPTION FOR ZOFRAN, AND WAS INSTRUCTED TO TAKE BENADRYL. BASED ON THE INFORMATION PROVIDED BY BOTH THE PROVIDER AND THE PATIENT, THE ADJUSTMENT MADE TO ADDRESS MOVEMENT MAY HAVE INADVERTENLY IRRITATED THE PATIENT'S RIGHT TRIGEMINAL NERVE BASED ON THE PATIENT'S DESCRIPTION OF WHERE HE FELT THE DISCOMFORT. THE IRRITATION MAY HAVE SUBSEQUENTLY TRIGGERED THE PATIENT'S HEADACHE.

Description of Event or Problem

NEURONETICS RECEIVED A CALL FROM A PROVIDER INITIALLY REQUESTING ASSISTANCE TO ADDRESS A PATIENT WHO WAS HAVING DISCOMFORT FOLLOWING THEIR 24TH TREATMENT SESSION. THE PROVIDER REPORTED THAT THE PATIENT CLAIMS TO HAVE HAD A HEADACHE FOLLOWING TREATMENT AND HAD TO GO TO URGENT CARE AS A RESULT.