NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

TMS PROVIDER REPORTED TO NEURONETICS THAT ONE OF THEIR PATIENTS HAD A WORSENING OF LEFT LEG TREMORS ON THEIR 25TH TREATMENT SESSION THOUGH PATIENT INITIALLY REPORTED THIS TO THE OFFICE ON HER 21ST TREATMENT. PATIENT HAS HAD A HISTORY OF A "PALSY" TREMOR IN HER LEFT LEG PRIOR TO TMS AND HAS SEEN A NEUROLOGIST IN THE PAST REGARDING THE TREMOR HOWEVER THEY WERE UNABLE TO DETERMINE ITS CAUSE. REPORTEDLY, THE TREMOR WORSENS WITH STRESS OR ANXIETY. PATIENT HAD REPORTEDLY LOST A SIGNIFICANT AMOUNT OF WEIGHT OVER THE LAST YEAR AND HAS BEEN EXPERIENCING "PSYCHOSIS" SYMPTOMS POST COVID. TMS TREATER LATER REPORTED TO NEURONETICS THAT THEY WITNESSED THE TREMOR SINCE THE BEGINNING OF TREATMENT AND NOTED THAT IT HAD SEEMINGLY PROGRESSED OVER THE COURSE OF TREATMENT. THE TREMOR REPORTEDLY WAS NOT WORSENED BY THE PULSES NOR HAD IT WORSENED THROUGHOUT INDIVIDUAL DAILY TREATMENTS. PATIENT HAS COMPLETED TMS TREATMENT. PATIENT WILL BE FOLLOWING UP WITH NEUROLOGIST AS THE HUSBAND EXPRESSED CONCERN THAT THE WIFE HAS A MAJOR HEALTH ISSUE UNRELATED TO TMS.

Description of Event or Problem

NEURONETICS RECIEVED A CALL FROM A TMS PROVIDER REPORTING THAT ONE OF THEIR PATIENTS HAD BEEN EXPERIENCING INCREASED LEG TWITCHING DURING AND OUTSIDE OF TMS TREATMENT.