NEUROSTAR ADVANCED THERAPY

Description of Event or Problem

PROVIDER CONTACED NEURONETICS TO REPORT A PATIENT WHO HAD EXPERIENCED A SEIZURE DURING THEIR 17TH TREATMENT SESSION.

Additional Manufacturer Narrative

NEURONETICS WAS CONTACTED BY A PROVIDER THAT REPORTED ONE OF THEIR PATIENTS HAD EXPERIENCED A SEIZURE ABOUT 10 MINUTES INTO THEIR 17TH TREATMENT SESSION. PATIENT'S VITALS WERE MONITORED AT THE PROVIDER'S OFFICE AND PATIENT'S SPOUSE WAS CALLED FOLLOWING THE EVENT. PATIENT WAS TAKEN BACK HOME BY SPOUSE. PROVIDER FOLLOWED UP WITH THE PATIENT THE NEXT DAY FOLLOWING THE EVENT WHO REPORTED THAT SHE WAS "STILL STIFF/HURTING" LAST NIGHT BUT DID NOT HAVE A HEADACHE. PATIENT HAD REQUESTED PROVIDER REFER HER TO NEUROLOGY. THE REFERRED NEUROLOGIST REQUESTED THAT THE PATIENT GO TO THE ER TO FACILIATE ACCESS TO AN EARLIER APPOINTMENT. ER NOTES THAT AT THE TIME OF VISIT: PATIENT HAD NOT CONTINUED WITH TMS, HAS NOT EXPERIENCED ANY MORE SEIZURES, AND EXPRESSES THAT SHE WOULD LIKE TO CONTINUE WITH TMS. PER ER NOTES, PATIENT'S EXAM WAS NORMAL AND NEUROLOGY HAS CLEARED THE PATIENT TO RETURN FOR TMS WITH SEIZURE PRECAUTIONS IN THE OFFICE. DESPITE BEING CLEARED BY NEUROLOGY TO CONTINUE WITH TREATMENT, PATIENT HAS DECIDED NOT TO CONITNUE AT THIS TIME.