inforMED
InjuryOBP

NEUROSTAR

Received Jun 11, 2025 · Event occurred Nov 1, 2022

Report MW5171362 · MDR key 22188521

Device

Generic name

Transcranial Magnetic Stimulator

Manufacturer

Unknown

Product problems

  • Human-Device Interface Problem

Patient

35 YR · Female

  • Fall
  • Fatigue
  • Headache
  • Memory Loss/Impairment
  • Vertigo
  • Anxiety
  • Depression
  • Hallucination
  • Fall
  • Fatigue
  • Headache
  • Memory Loss/Impairment
  • Vertigo
  • Anxiety
  • Depression
  • Hallucination

Narrative

Description of Event or Problem

I AM A MASTER'S LEVEL MENTAL HEALTH COUNSELOR. I PURSUED TMS (TRANSCRANIAL MAGNETIC STIMULATION) THERAPY TREATMENT IN (B)(6) 2022 FOR TREATMENT-RESISTANT DEPRESSION, AFTER TRYING EVERYTHING ELSE IN THE BOOK FOR OVER A DECADE. I EXPERIENCED SEVERE, DISABLING, AND LASTING SIDE EFFECTS DURING THIS TREATMENT AND STILL EXPERIENCE THEM YEARS LATER. I WOULD BE HAPPY TO SEND ME RECORDS FROM MY TREATMENTS, ALTHOUGH THEY DON'T ADEQUATELY DESCRIBE WHAT I EXPERIENCED. SAYING THERE ARE NO LASTING SIDE EFFECTS OF TMS IS A DOWNRIGHT LIE, AND ALL OF THE SIDE EFFECTS I EXPERIENCED ARE NOT ON THE SIDE EFFECT LIST. IT'S IRRESPONSIBLE TO FLOUT THIS TREATMENT WITHOUT EDUCATING CONSUMERS ON THE POSSIBLE SIDE EFFECTS. IT HAS BEEN IMPOSSIBLE TO FIND NEGATIVE INFORMATION ON THE INTERNET SO IT'S CLEAR THAT IT'S BEING HUSHED UP- THE TREATMENT MAKES TOO MUCH MONEY. THERE ARE CLINICS THAT JUST DO TMS SESSIONS ALL DAY LONG. AS A CLINICIAN IN PRIVATE PRACTICE, I'VE ALSO HAD CLIENTS REPORT NEGATIVE SIDE EFFECTS AS WELL INCLUDING FEELING DRUNK OR LIKE THEY'RE PASSING OUT, HAVING TO CANCEL THEIR WORK SHIFTS, FEELING MORE ANXIOUS AND DEPRESSED, ETC. THE TREATMENT IS SUPPOSED TO HELP DEPRESSION, BUT THEY OFTEN USE IT AS A "CATCH ALL" THESE DAYS- LIKE THEY NOW DO FOR ANTIDEPRESSANTS WHICH GET PRESCRIBED FOR EVERYTHING FROM CHRONIC PAIN TO SMOKING CESSATION TO DEPRESSION. DURING MY TREATMENTS I EXPERIENCED SEVERE AND DISABLING DIZZINESS AND VERTIGO, DISSOCIATION, MEMORY LOSS, LOSS OF BALANCE AND FALLING OVER (AND I'M IN MY THIRTIES, I HAD NO HEALTH OR COGNITIVE ISSUES). I EXPERIENCED CRIPPLING ANXIETY AND PANIC ATTACKS, VISUAL HALLUCINATIONS (LIKE THE WALLS BREATHING OR THE FLOOR UNDULATING), CONSTANT DAILY HEADACHES AND MIGRAINES, AND ULTIMATELY WORSENING DEPRESSION. I CONTINUED THE TREATMENTS BECAUSE I WAS TOLD THIS "DIP" SHOULD GO AWAY IN A COUPLE OF WEEKS. ALSO, I COULDN'T FIND ANYTHING LIKE THIS ON THE INTERNET, THE NEGATIVE EXPERIENCES WERE BURIED AND ALMOST IMPOSSIBLE TO FIND, SO I HONESTLY THOUGHT MY BRAIN WAS SOMEHOW HEALING ITSELF. THAT "DIP" THAT PEOPLE TALK ABOUT NEVER DID GO AWAY, AND YEARS LATER I STILL EXPERIENCE SYMPTOMS DAILY, AND THEY ARE WORSE DEPENDING ON THE DAY. I STILL HAVE BRAIN FOG AND CONFUSION, SHORT TERM MEMORY ISSUES, I ALWAYS FEEL LIKE I'M ON A BOAT AND THE WORLD IS TILTING OR JUMPING AROUND ME, I'M EASILY EXHAUSTED AND CANNOT WORK FULL-TIME. SO, THIS TREATMENT DISABLED ME, AND IT'S DISABLING OTHER PEOPLE AS WE SPEAK. THERE ARE ONLINE FORUMS AND FACEBOOK GROUPS OF PEOPLE WHO EXPERIENCED THE SAME EXACT THINGS I DID, BUT NO ONE CAN GET ANY HELP. WE'VE ALL BEEN IRREVERSIBLY MAIMED BY THIS TREATMENT. AS A MENTAL HEALTH PROFESSIONAL WHO HAS BEEN RECEIVING VARIOUS TREATMENTS MY ENTIRE ADULT LIFE, MY OPINION SHOULD HOLD SOME WATER. THIS TREATMENT IS DANGEROUS, AND IF YOU'RE GOING TO CONTINUE VOUCHING FOR IT, AT LEAST BE HONEST ABOUT ALL OF THE POTENTIAL SIDE EFFECTS. I'M PRETTY SURE I'VE SENT ONE OF THESE FORMS IN BEFORE, BUT IT WAS NEVER ANSWERED, GO FIGURE. NO ONE IS GOING TO DO ANYTHING ABOUT THIS. BUT SOMEONE SHOULD BEAR WITNESS TO THE HARM THIS IS CAUSING PEOPLE. SOMEONE SHOULD DO SOMETHING. EVER SINCE TMS I EXPERIENCE SEVERE SIDE EFFECTS TO PHARMACEUTICALS LIKE ANTIDEPRESSANTS, SO I HAVE UNTREATED MENTAL HEALTH SYMPTOMS.