NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

ON THE DAY OF THE EVENT, THE INDIVIDUAL SAID SHE DID NOT FEEL COMFORTABLE DRIVING HERSELF HOME. TEXT MESSAGES FROM THE INDIVIDUAL TO PROVIDER OVER THE TWO DAYS FOLLOWING THE TREATMENT SAID SHE WAS FEELING LITTLE BETTER AND AGREED THAT COULD POSSIBLY BE A MIGRAINE. THE VOLUNTEER WAS OUT OF WORK FOR ABOUT 3 WEEKS, HAD MEDICATION CHANGES, AND ADDITIONAL MEDS PRESCRIBED TO TREAT HER MIGRAINES. THE INDIVIDUAL RETURNED TO WORK THE WEEK OF 3/17/26 FOR FULL DAYS. SHE SAYS THE MIGRAINES ARE BETTER BUT STILL GETS HEADACHES AND IS SENSITIVE TO NOISE AND LIGHT. SHE SAYS THAT SHE IS NOW EXPERIENCING TERRIBLE BRAIN FOG, AND HER OVERALL MENTAL HEALTH ISSUES ARE WORSE. THERE MAY BE OTHER FACTORS INVOLVED AS WELL SINCE THE INDIVIDUAL WAS UNDER A LOT OF STRESS IN THE WEEKS PRIOR TO THE EVENT, HAS A HISTORY OF MIGRAINES AND POSSIBLE OTHER MEDICAL CONCERNS. SHE HAS HAD AN MRI AND IS WAITING FOR RESULTS.

Description of Event or Problem

A PROVIDER'S NURSE WAS A TRAINING VOLUNTEER FOR DOING A TMS MT. THE INDIVIDUAL ALSO RECEIVED A SINGLE ITBS (TOUCHSTAR THETA BURST) TREATMENT AT 35-50% OF THE DETERMINED POWER FOLLOWING THE MT. ABOUT AN HOUR LATER SHE EXPERIENCED A HEADACHE, DIZZINESS, AND FELT LIKE SHE WAS HAVING AN ANXIETY ATTACK. SHE MISSED TWO DAYS OF WORK INITIALLY BUT ENDED UP MISSING ABOUT 3 WEEKS.