NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

TMS PROVIDER REPORTED THAT ONE OF THEIR PATIENTS WAS EXPERIENCING INCREASING DISCOMFORT OVER THE COURSE OF 3 TREATMENT SESSIONS. PROVIDER STATED THAT ADJUSTMENTS WERE MADE IN AN ATTEMPT TO ALLEVIATE THE DISCOMFORT PER NEUROSTAR RECOMMENDATIONS BUT PATIENT DECIDED TO STOP TREATMENT. PATIENT LATER REPORTED TO THE PROVIDER THAT SINCE RECEIVING TREATMENT, SHE HAS BEEN EXPERIENCING SEVERE MIGRAINES, HAS BEEN UNABLE TO SLEEP THROUGH THE NIGHT, AND HAS HAD A SIGNIFICANT DECLINE IN HER ABILITY TO PERFORM DAILY ACTIVITIES. PATIENT HAS A HISTORY OF CHRONIC MIGRAINES AND HAS BEEN SEEN BY A NEUROLOGIST FOR THEM PRIOR TO RECEIVING TMS. PATIENT CLAIMS THAT POST TREATMENT SHE FAILED A PROPRIOCEPTION TEST WITH HER NEUROLOGIST THOUGH THE TMS PROVIDER'S OFFICE DOES NOT HAVE ANY RECORD OF THIS. THE PATIENT REPORTED THAT SHE SAW A NEUROLOGIST AND CONCLUDED THAT THE PATIENT "MAY HAVE NERVE OR BLOOD VESSEL STIMULATION." THE TMS PROVIDER NEVER RECEIVED FURTHER CLARIFICATION OR RECORDS FROM THE NEUROLOGIST TO SUBSTANTIATE THESE CLAIMS.

Description of Event or Problem

PROVIDER CONTACTED NEURONETICS TO REPORT A PATIENT WHO HAD EXPERIENCED SEVERE DISCOMFORT DURING TMS TREATMENT AND BEGAN TO EXPERIENCE SEVERE MIGRAINES POST TREATMENT.