inforMED
InjuryOBP

NERUOSTAR

Received Apr 21, 2025 · Event occurred Jun 28, 2023

Report MW5169340 · MDR key 21874090

Device

Generic name

Transcranial Magnetic Stimulator

Manufacturer

Neuronetics Inc.

Product problems

  • Patient-Device Incompatibility
  • Therapeutic or Diagnostic Output Failure

Patient

33 YR · Female

  • Headache
  • Device Overstimulation of Tissue
  • Pain
  • Dizziness
  • Brain Injury
  • Distress
  • Discomfort
  • Ambulation or Postural Difficulties
  • Headache
  • Device Overstimulation of Tissue
  • Pain
  • Dizziness
  • Brain Injury
  • Distress
  • Discomfort
  • Ambulation or Postural Difficulties

Narrative

Description of Event or Problem

ON (B)(6) 2023, I ATTENDED A SCHEDULED MAPPING SESSION FOR TMS (TRANSCRANIAL MAGNETIC STIMULATION) AT (B)(6). I HAD MADE IT EXPLICITLY CLEAR--BOTH VERBALLY AND VIA TEXT--THAT I DID NOT WISH TO BEGIN TREATMENT UNTIL AFTER AN UPCOMING MARATHON AND FAMILY TRIP. DESPITE THIS, WHEN I ARRIVED, I WAS TOLD I WOULD BEGIN TREATMENT THAT SAME DAY. MY HUSBAND AND I EXPRESSED CONCERNS, ESPECIALLY SINCE WE HAD BEEN TOLD THAT TMS IS MOST EFFECTIVE WITH CONSISTENT SESSIONS. THE PSYCHIATRIST REASSURED US THAT IT WAS PAINLESS, THAT I URGENTLY NEEDED THE TREATMENT, AND THAT A SHORT BREAK AFTER STARTING WOULD BE ACCEPTABLE. DURING THE MAPPING, THE TEAM COULD NOT FIND MOVEMENT IN MY THUMB, WHICH IS THE STANDARD FOR IDENTIFYING THE MOTOR CORTEX. INSTEAD, THEY FOUND MOVEMENT IN MY RING FINGER AND MOVED 5 CM FORWARD TO TARGET MY TREATMENT LOCATION--WITHOUT GIVING ME A CHANCE TO SEE OR VERIFY THE MUSCLE RESPONSE. MAPPING FELT UNCOMFORTABLE BUT TOLERABLE. HOWEVER, WHEN TREATMENT BEGAN IMMEDIATELY AFTERWARD, THE PAIN WAS SEVERE AND UNEXPECTED--SHARP, JARRING, AND NOTHING LIKE THE LIGHT TAPPING OR RUBBER BAND SNAP I WAS TOLD TO EXPECT. I RATED THE PAIN 8-9 OUT OF 10. THE PSYCHIATRIST WAS VISIBLY SURPRISED BUT DID NOT STOP THE SESSION. INSTEAD, SHE COMPLETED THE FULL 19-MINUTE TREATMENT, TELLING ME THE PAIN WOULD IMPROVE WITH TIME AND THAT MY UPCOMING TREATMENT BREAK WOULD HELP ME HEAL. AFTER THE SESSION, I WAS IN EMOTIONAL AND PHYSICAL DISTRESS. I CRIED FOR HOURS, EXPERIENCED DISASSOCIATION, AND WAS UNABLE TO FUNCTION. DESPITE THIS, I RETURNED ON (B)(6), HOPING THE STAFF WOULD ADJUST THE APPROACH. I WAS SEEN BY A MORE EXPERIENCED TECHNICIAN WHO LOWERED THE MACHINE'S INTENSITY SLIGHTLY AND ADJUSTED THE COIL ANGLE. THE PAIN REMAINED INTENSE, BUT I WAS TOLD THIS REACTION COULD BE DUE TO OVERSTIMULATION AND THAT IT SHOULD IMPROVE OVER TIME. I WAS TOLD BOTH THE EXPERIENCED TECHNICIAN AND PSYCHIATRIST WOULD BE PRESENT FOR MY THIRD SESSION ON (B)(6)--BUT WHEN I ARRIVED, NEITHER WERE THERE. I WAS TREATED BY A DISENGAGED TECH WITH NO COMMUNICATION ABOUT MY PRIOR EXPERIENCES. THE PAIN WAS AGAIN SEVERE, AND I BEGAN EXPERIENCING A NEW SYMPTOM: MOTOR COORDINATION ISSUES--STRUGGLING TO PICK UP OBJECTS, KNOCKING THINGS OVER, AND GENERALLY FEELING LIKE MY BODY WASN'T RESPONDING CORRECTLY. THIS WAS ACCOMPANIED BY ONGOING HEADACHES, DIZZINESS, EMOTIONAL DISTRESS, AND A SENSE OF MENTAL DETACHMENT. ON (B)(6) 2023, I WENT TO THE EMERGENCY ROOM BECAUSE MY SYMPTOMS HAD NOT SUBSIDED. I FAILED A BASIC NEUROLOGICAL EXAM, SPECIFICALLY THE TEST WHERE YOU TOUCH YOUR NOSE WITH YOUR EYES CLOSED--SOMETHING I HAD NEVER FAILED BEFORE. ON (B)(6), I MET WITH THE SAME PSYCHIATRIST WHO HAD OVERSEEN MY TMS MAPPING. SHOCKINGLY, SHE HAD NO IDEA THAT I HAD STOPPED TREATMENT AT THE CLINIC AND WAS COMPLETELY UNAWARE OF THE INTENSITY OF PAIN I EXPERIENCED, DESPITE HER STAFF HAVING TOLD ME THEY WOULD KEEP HER INFORMED. ON (B)(6) 2023, I UNDERWENT A SPECT BRAIN SCAN, WHICH LATER SHOWED DAMAGE TO THE LEFT SIDE OF MY BRAIN¿EXACTLY WHERE THE TMS COIL HAD BEEN POSITIONED DURING TREATMENT. ON (B)(6) 2024, FOLLOWING A REFERRAL FROM MY OPTOMETRIST, I WAS SEEN BY A NEURO-OPTOMETRIST, WHO NOTED SEVERE VISUAL DEFICITS CONSISTENT WITH A TRAUMATIC BRAIN INJURY. THESE FINDINGS WERE OBJECTIVE AND CONCLUSIVE. ON (B)(6) 2024, I WAS OFFICIALLY DIAGNOSED WITH A BRAIN INJURY WITHOUT LOSS OF CONSCIOUSNESS BY A SPORTS MEDICINE PHYSICIAN. I BELIEVE (B)(6) FAILED IN THEIR DUTY OF CARE ON MULTIPLE LEVELS: FAILING TO SCREEN PROPERLY FOR TMS TOLERANCE, MISREPRESENTING THE RISKS, DOWNPLAYING MY PAIN, AND CONTINUING TREATMENT DESPITE MY CLEAR DISTRESS. MY ATTEMPTS TO DELAY TREATMENT WERE IGNORED, MY SYMPTOMS WERE NOT DOCUMENTED OR SHARED WITH THE PRESCRIBING PSYCHIATRIST, AND FOLLOW-UP CARE WAS NON-EXISTENT. I AM SUBMITTING THIS COMPLAINT TO ENSURE THAT PROPER OVERSIGHT IS ENFORCED, THAT REPORTING SYSTEMS ARE IMPROVED, AND TO HELP PROTECT FUTURE PATIENTS FROM THE SAME HARM. A NEUROSTAR DEVICE WAS USED. PRIOR TO TMS TREATMENT, I WAS IN OVERALL GOOD PHYSICAL HEALTH WITH NO HISTORY OF NEUROLOGICAL INJURY, BRAIN TRAUMA, SEIZURES, OR COORDINATION ISSUES. I WAS PHYSICALLY ACTIVE, TRAINING FOR A MARATHON, AND FUNCTIONING INDEPENDENTLY IN BOTH PERSONAL AND PROFESSIONAL LIFE. MY SOLE MENTAL HEALTH DIAGNOSIS WAS POST-TRAUMATIC STRESS DISORDER (PTSD), FOR WHICH I WAS SEEKING TREATMENT. I DID NOT HAVE A HISTORY OF DEPRESSION, ANXIETY, BIPOLAR DISORDER, SCHIZOPHRENIA, OR PERSONALITY DISORDERS. I HAD NO CARDIOVASCULAR CONDITIONS SUCH AS HIGH BLOOD PRESSURE, HEART DISEASE, OR ARRHYTHMIA. I ALSO HAD NO HISTORY OF DIABETES, CANCER, AUTOIMMUNE DISORDERS, OR OTHER SYSTEMIC HEALTH CONDITIONS. I WAS NOT ON MEDICATIONS THAT WOULD CONTRAINDICATE BRAIN STIMULATION. MY VISION WAS NORMAL WITH PRESCRIPTION LENSES, AND I HAD NEVER EXPERIENCED VISUAL DISTURBANCES, DIZZINESS, HEADACHES, MIGRAINES, OR DISSOCIATION PRIOR TO TREATMENT. THERE WAS NO HISTORY OF TRAUMATIC HEAD INJURY, STROKE, OR COGNITIVE IMPAIRMENT. I HAD NO PRIOR PSYCHIATRIC HOSPITALIZATIONS OR EMERGENCY INTERVENTIONS. OVERALL, I WAS CONSIDERED HEALTHY AND STABLE WITH PTSD BEING THE ONLY DIAGNOSIS FOR WHICH TREATMENT WAS BEING PURSUED.