NEUROSTAR

Additional Manufacturer Narrative

THE PATIENT DID RESPOND TO QUESTIONS FROM NEURONETICS AND REPORTED THAT THE MIGRAINES HAVE REDUCED IN FREQUENCY. SHE COMPLETED HER DEGREE AND IS CURRENTLY WORKING. BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE ON HOW TMS MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S MIGRAINES. DURING COMMUNICATION WITH THE PATIENT, SHE DID STATE THAT THE TICS WERE MOST LIKELY DUE TO THE MEDICATION SHE WAS TAKING AT THE TIME OF TMS TREATMENT.

Description of Event or Problem

NEURONETICS RECEIVED A MEDWATCH FROM FDA (MW5172397) ALLEGING THAT A PATIENT RECEIVED TMS (NEUROSTAR) TREATMENT IN 2023 RESULTED IN RECURRING, UNILATERAL MIGRAINES ON THE SAME SIDE THAT SHE WAS TREATED WITH TMS. ADDITIONALLY, THE PATIENT ALLEGES THAT SHE HAS A TIC ON THE LEFT SIDE OF HER FACE, WHICH IS A COMMON SIDE-EFFECT OF A DRUG SHE WAS TAKING AT THE TIME OF HER TMS TREATMENT. HOWEVER, AFTER STOPPING THE DRUG, THE TIC REMAINED. THE REPORTER STATES THAT SHE "CAN'T CONFIDENTLY ATTRIBUTE ALL THE MIGRAINES TO TMS..." AND THERE IS NO INFORMATION THAT SHE HAS RECEIVED A DIAGNOSIS FROM A NEUROLOGIST.