NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

NEURONETICS RECEIVED AN EMAIL FROM A PATIENT ALLEGING THAT AFTER RECEIVING TMS, SHE EXPERIENCED EXTREME FATIGUE, HORRIBLE HEADACHES, AND 3 SEIZURES. NEURONETICS FOLLOWED UP WITH THE PATIENT TO GATHER MORE INFORMATION ON THE ALLEGED COMPLAINTS, AND PATIENT REITERATED EXPERIENCING THE ALLEGED COMPLAINTS BUT CLARIFIED THAT SHE ONLY EXPERIENCED 1 SIEZURE WHILE SHE WAS BY HERSELF. PATIENT REPORTED THAT AT THE TIME OF THE ALLEGED SEIZURE, SHE WAS SLEEP DEPRIVED, DEHYDRATED, AND HEAVILY CAFFEINATED. FOLLOWING THE EVENT, PATIENT WAS REFERRED TO A NEUROLOGIST AND RECEIVED AN EEG THAT WAS NORMAL. NEURONETICS ATTEMPTED MULTIPLE TIMES TO REACH OUT TO THE PROVIDER'S OFFICE WHERE THE PATIENT RECEIVED TMS TO GATHER ADDITIONAL INFORMATION ON THE COMPLAINT BUT HAS BEEN UNSUCCESSFUL. NEURONETICS IS REPORTING OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem

NEURONETICS RECEIVED AN EMAIL FROM A PATIENT ALLEGING THAT AFTER RECEIVING A TOTAL OF 40 TREATMENTS SHE EXPERIENCED EXTREME FATIGUE, HORRIBLE HEADACHES, AND SEIZURES.