inforMED
InjuryOBP

NEUROSTAR TMS THERAPY SYSTEM

Received Apr 28, 2026 · Event occurred Dec 10, 2024

Report MW5187360 · MDR key 25016763

Device

Generic name

Transcranial Magnetic Stimulator

Manufacturer

Neuronetics, Inc.

Patient

Female

  • Headache
  • Hypersensitivity/Allergic reaction
  • Pain
  • Discomfort
  • Eye Pain

Narrative

Description of Event or Problem

I UNDERWENT TRANSCRANIAL MAGNETIC STIMULATION (TMS) USING THE NEUROSTAR TMS THERAPY SYSTEM FOR OVER 80 SESSIONS, COVERED BY INSURANCE, FOLLOWED BY MAINTENANCE TREATMENTS. MAINTENANCE BEGAN AT FIVE SESSIONS PER WEEK AND WAS LATER REDUCED TO 2¿3 SESSIONS WEEKLY. DURING TREATMENT, I DEVELOPED SIGNIFICANT PAIN AND HEADACHES BOTH DURING AND OUTSIDE OF SESSIONS, ALONG WITH INCREASING SCALP SENSITIVITY. I REPORTED THESE SYMPTOMS TO THE TMS TECHNICIAN; THE STIMULATION INTENSITY WAS BRIEFLY LOWERED BUT THEN INCREASED AGAIN DESPITE CONTINUED PAIN. MY CONCERNS ABOUT WORSENING SYMPTOMS WERE NOT ADEQUATELY ADDRESSED, AND I WAS ENCOURAGED TO CONTINUE TREATMENT DESPITE ONGOING DISCOMFORT. I DISCONTINUED TMS IN LATE (B)(6) 2024 DUE TO THESE ADVERSE EFFECTS. SINCE DISCONTINUATION, I HAVE EXPERIENCED PERSISTENT SYMPTOMS LASTING OVER 12 MONTHS AND CONTINUING AS OF (B)(6) 2026, INCLUDING HEADACHES/MIGRAINES, SPONTANEOUS SCALP PAIN, PAIN TRIGGERED BY LIGHT TOUCH OR PRESSURE (E.G., WEARING A PONYTAIL OR SUNGLASSES ON HEAD), SENSITIVITY TO AIR MOVEMENT AND TEMPERATURE CHANGES (E.G., A LIGHT FAN OR CAR AIR CONDITIONING), SPONTANEOUS EYE PAIN, AND LOCALIZED SCALP PAIN. THESE SYMPTOMS HAVE SIGNIFICANTLY IMPACTED MY DAILY FUNCTIONING AND HAVE PERSISTED WELL BEYOND THE TREATMENT PERIOD. I HAVE REPORTED THESE ONGOING SYMPTOMS TO MY PSYCHIATRIST AND PRIMARY CARE PROVIDER, WHO ARE CURRENTLY ASSISTING IN EFFORTS TO MANAGE THE PAIN I AM EXPERIENCING.