NEUROSTAR TMS
Received Jun 12, 2025 · Event occurred Aug 5, 2024
Report MW5171425 · MDR key 22196967
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
35 YR · Female
- Fatigue
- Fever
- Tachycardia
- Distress
- Neck Pain
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Fatigue
- Fever
- Tachycardia
- Distress
- Neck Pain
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
I HAVE STRUGGLED WITH TREATMENT-RESISTANT DEPRESSION FOR MANY YEARS AND DECIDED TO PURSUE TRANSCRANIAL MAGNETIC STIMULATION (TMS) THERAPY AFTER OTHER TREATMENTS WERE INEFFECTIVE. I WAS ASSURED THAT TMS WAS PAINLESS AND THAT ANY DISCOMFORT COULD BE ADJUSTED. DURING THE FIRST FEW SESSIONS AT LOWER INTENSITY LEVELS, I EXPERIENCED NO PAIN. HOWEVER, ONCE THE INTENSITY WAS INCREASED BASED ON MY MOTOR THRESHOLD, I BEGAN TO FEEL PAIN DURING THE TREATMENTS--SPECIFICALLY IN MY NECK AND THROAT AREA. THE PAIN WORSENED WITH EACH SESSION. I INFORMED THE CLINIC, AND THEY RETESTED AND SLIGHTLY LOWERED THE INTENSITY, BUT I WAS TOLD THAT IF THE LEVEL WAS TOO LOW, THE TREATMENT MIGHT NOT BE EFFECTIVE. SO I TRIED TO ENDURE THE PAIN. AFTER ABOUT TWO WEEKS OF SESSIONS, I DEVELOPED A FEVER THAT RETURNED NIGHTLY FOR 14 CONSECUTIVE DAYS, ALONG WITH SEVERE FATIGUE AND AN ELEVATED HEART RATE. I VISITED URGENT CARE, WHERE THEY DISMISSED IT AS A POSSIBLE INFECTION. BUT AFTER CONTINUING SYMPTOMS, I RETURNED TO URGENT CARE, WHERE THEY NOTICED MY HIGH HEART RATE AND REFERRED ME FOR AN EKG. I WAS THEN REFERRED TO AN ENDOCRINOLOGIST AND DIAGNOSED WITH ACUTE THYROIDITIS. MY TSH LEVELS WERE EXTREMELY ELEVATED, DESPITE NO PRIOR THYROID ISSUES. EVEN MINIMAL ACTIVITY RAISED MY HEART RATE DANGEROUSLY. I HAD TO TAKE MEDICATION TO MANAGE THIS AND WAS TOLD TO AVOID ALL PHYSICAL ACTIVITY. I MISSED SO MUCH WORK THAT I HAD TO APPLY FOR FMLA (FAMILY AND MEDICAL LEAVE ACT) TO PROTECT MY JOB. I WASN'T TAKING ANY NEW MEDICATIONS OR UNDERGOING OTHER TREATMENTS. I HAD NO PRIOR HISTORY OF THYROID ISSUES, AND THE ONLY CHANGE IN MY ROUTINE WAS THE INITIATION OF TMS THERAPY. I BELIEVE THERE IS A LINK BETWEEN THE TMS TREATMENT AND THE ONSET OF MY THYROIDITIS. WHEN I PRESENTED THIS CONCERN TO MY HEALTHCARE PROVIDERS, IT WAS DISMISSED AS UNRELATED. HOWEVER, I FOUND STUDIES INDICATING THAT TMS CAN INFLUENCE THYROID HORMONE LEVELS, WHICH RAISES CONCERNS ABOUT ITS EFFECTS ON INDIVIDUALS WITH NORMAL THYROID FUNCTION. I AM SUBMITTING THIS REPORT TO HIGHLIGHT A POTENTIAL ADVERSE EFFECT OF TMS THERAPY THAT MAY NOT BE WIDELY RECOGNIZED. I HOPE THIS INFORMATION CONTRIBUTES TO A BETTER UNDERSTANDING OF THE THERAPY'S RISKS AND ENCOURAGES FURTHER INVESTIGATION INTO ITS SAFETY PROFILE. LABORATORY RESULTS SHOWED SUPPRESSED TSH AND SIGNIFICANTLY ELEVATED TOTAL T4 LEVELS, CONSISTENT WITH THYROIDITIS. FREE T4 LEVELS LATER NORMALIZED, AND NO THYROID AUTOANTIBODIES WERE DETECTED, INDICATING THE ABSENCE OF AUTOIMMUNE THYROID CONDITIONS SUCH AS HASHIMOTO'S THYROIDITIS OR GRAVES' DISEASE. THESE FINDINGS SUPPORT A DIAGNOSIS OF ACUTE, NON-AUTOIMMUNE THYROIDITIS LIKELY TRIGGERED BY AN EXTERNAL OR ENVIRONMENTAL FACTOR.