NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

PATIENT'S DEPRESSION IMPROVED WITH THE TMS TREATMENT. SOME OF HER SIDE EFFECTS WERE EXISTING CONDITIONS PRIOR TO STARTING TMS ACCORDING TO THE PRACTICE THAT TREATED HER. AT HER POST-TREATMENT FOLLOW UP VISIT, THE PROVIDER SUGGESTED SHE RETURN FOR ADDITIONAL TREATMENT SHOULD HER SYMPTOMS WORSEN. HOWEVER, THE PATIENT DID NOT FOLLOW UP WITH THAT PROVIDER. SINCE BIPOLAR DISEASE IS CONSIDERED AN UNSTUDIED PATIENT POPULATION AND CONSIDERED OFF-LABEL USE, IT IS NOT KNOWN IF THIS CONDITION CONTRIBUTED TO THE SIDE EFFECTS. THE PATIENT ALSO MENTIONED THAT ALL OF HER MEDICATIONS WERE CHANGED IN (B)(6) 2024.

Description of Event or Problem

PATIENT CALLED NEUROMETRICS TO COMPLAIN ABOUT HER EXPERIENCE WITH TMS TREATMENT THAT OCCURRED IN 2023. SHE ALLEGES THAT SHE WAS TREATED WITH A FULL COURSE OF TMS IN (B)(6) 2023 AND THAT AFTER A FEW WEEKS OF HER TREATMENT ENDING, SHE EXPERIENCED DEBILITATING ANXIETY AND PANIC ATTACKS AS WELL AS INSOMNIA.