NEUROSTAR ADVANCED THERAPY
Received Jul 1, 2026 · Event occurred May 3, 2026
Report 3004824012-2026-00015 · MDR key 25682241
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Shaking/Tremors
Narrative
Additional Manufacturer Narrative
ABOUT 5-10 MINUTES AFTER COMPLETING A DAILY TMS TREATMENT, THE PATIENT EXPERIENCED UNCONTROLLABLE MUSCLE TWITCHING, SPASMS, AND STIFFNESS, LEFT ARM THEN RIGHT ARM. THE PATIENT HAD TO PULL OVER AS SHE WAS DRIVING AND SHE WAS UNABLE TO SPEAK. IT WAS DETERMINED THAT THE PATIENT WAS EXPERIENCING SEROTONIN SYNDROME. THE TMS PROVIDER AGREES THIS WAS SEROTONIN SYNDROME, DUE TO EFFEXOR, CYMBALTA, TRAZODONE, AND TMS ADDED A SMALL PERCENTAGE OF INCREASED SEROTONIN RECEPTORS. THE PATIENT WENT TO THE ER AND WAS ADMITTED OVERNIGHT FOR OBSERVATION. SHE WAS ADMINISTERED VALIUM AND HAD TWO OF HER THREE SNRIS & A TETRACYCLIC MEDICATION WITHDRAWN. PATIENT RESTARTED TMS AND HAS BEEN DOING WELL WITH THE TREATMENT.
Description of Event or Problem
ABOUT 5-10 MINUTES AFTER COMPLETING A DAILY TMS TREATMENT, THE PATIENT EXPERIENCED UNCONTROLLABLE MUSCLE TWITCHING, SPASMS, AND STIFFNESS, LEFT ARM THEN RIGHT ARM. THE PATIENT HAD TO PULL OVER AS SHE WAS DRIVING AND SHE WAS UNABLE TO SPEAK. IT WAS DETERMINED THAT SHE WAS EXPERIENCING SEROTONIN SYNDROME.