NEUROSTAR ADVANCED THERAPY

Description of Event or Problem

NEURONETICS RECEIVED A REPORT FROM A PROVIDER STATING THAT ONE OF HIS PATIENTS HAD PREVIOUSLY RECEIVED A COURSE OF TMS AT A DIFFERENT OFFICE AND REPORTEDLY DEVELOPED TINNITUS.

Additional Manufacturer Narrative

NEURONETICS WAS INITIALLY CONTACTED BY A PROVIDER REGARDING A QUESTION ABOUT THE INCIDENCE RATE OF TINNITUS FOLLOWING TMS. PROVIDER THEN DISCLOSED THAT WHILE DISCUSSING TMS AS A TREATMENT OPTION FOR ONE OF HIS NEW PATIENTS, THE PATIENT REPORTED TO HIM THAT SHE HAD RECEIVED A COURSE OF TMS IN 2022 AND EXERIENCED TINNITUS. THE PROVIDER REPORTED THAT THE PATIENT COULD NOT CONFIRM WHICH OFFICE SHE WAS TREATED AT IN 2022. NEURONETICS HAS ATTEMPTED TO OBTAIN MORE INFORMATION ON THE PATIENT AND COMPLAINT BUT HAS BEEN UNSUCCESSFUL. BASED ON THE INFORMATION AVAILABLE, NEURONETICS IS UNABLE TO CONFIRM WHETHER THE PATIENT WAS TREATED WITH A NEUROSTAR AT THE TIME OF THE ALLEGED COMPLAINT. NEURONETICS IS REPORTING OUT OF AN ABUDANCE OF CAUTION.