NEUROSTAR ADVANCED THERAPY
Received Mar 24, 2026 · Event occurred Feb 25, 2026
Report 3004824012-2026-00011 · MDR key 24680807
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
55 YR · Female
- Fatigue
- Headache
- Memory Loss/Impairment
- Dizziness
- Depression
- Sleep Dysfunction
- Cognitive Changes
- Unspecified Nervous System Problem
- Hallucination
- Unspecified Mental, Emotional or Behavioural Problem
- Unspecified Gastrointestinal Problem
Narrative
Additional Manufacturer Narrative
PATIENT NIGHTMARES HAVE IMPROVED. HOWEVER, SHE IS STILL HAVING WORSENED HALLUCINATIONS AND HAS CHOSEN TO STOP DRIVING FOR NOW SINCE SHE IS AFRAID THAT THINGS ARE GOING TO HURT HER. SHE IS STILL EXPERIENCING WORSENED DEPRESSION, INCREASED LACK OF MOTIVATION, AND INCREASED HEADACHES, SHE WAS REFERRED TO NEUROLOGY FOR THE HEAVY TONGUE, CONFUSION, BEING MORE FORGETFUL, VIVID NIGHTMARES, AND SLEEP PARALYSIS BUT HAS NOT YET HAD AN APPOINTMENT. HER PCP ORDERED HEAD AND CHEST X-RAYS BUT THE RESULTS ARE NOT BACK YET. THE RELATIONSHIP OF TMS TO ALL OF HER COMPLAINTS IS UNCLEAR. TMS IS NOT CLEARED BY THE FDA FOR PATIENTS WHO HAVE PSYCHOTIC FEATURES.
Description of Event or Problem
A PRACTICE REPORTED THAT A CURRENT TMS PATIENT PRESENTED FOR TREATMENT STATING THAT SHE WAS EXPERIENCING NIGHTMARES, VISION DISTORTION, SEEING OBJECTS THAT AREN'T THERE, AND LOUD NOISES BECOMING BOTHERSOME. SHE WANTED TO KNOW IF THESE THINGS WERE COMMON SIDE EFFECTS, WHICH THEY ARE NOT.