inforMED
InjuryOBP

TMS MACHINE BRAINSWAY

Received Aug 26, 2025 · Event occurred Nov 14, 2024

Report MW5175230 · MDR key 22896670

Device

Generic name

Transcranial Magnetic Stimulator

Manufacturer

Brainsway Ltd.

Product problems

  • Insufficient Device Problem Information

Patient

37 YR · Female

  • Arrhythmia
  • Memory Loss/Impairment
  • Tinnitus
  • Shaking/Tremors
  • Confusion/ Disorientation
  • Hallucination
  • Arrhythmia
  • Memory Loss/Impairment
  • Tinnitus
  • Shaking/Tremors
  • Confusion/ Disorientation
  • Hallucination

Narrative

Description of Event or Problem

I WAS PROVIDED TRANSCRANIAL MAGNETIC STIMULATION SERVICES IN WHICH MY TREATMENT PLAN WAS CHANGED MIDWAY THROUGH THE 36 SESSIONS AND CAUSED SIGNIFICANT COGNITIVE ISSUES AS WELL AS CENTRAL NERVOUS SYSTEM SYMPTOMS (HEART RATE IRREGULARITIES MOSTLY). THE MACHINE USED WAS BRAINSWAY AND WAS ADMINISTERED BY A LOCAL PSYCHIATRIST AND A TECHNICIAN. I STARTED THE 36 SESSIONS ON THE RIGHT PART OF MY BRAIN AND THEY DECIDED TO CHANGE TO A PROCEDURE THAT TARGETS BOTH SIDES OF YOUR BRAIN SIMULTANEOUSLY. AFTER ALL 36 TREATMENTS HAD BEEN ADMINISTERED I HAD PROBLEMS WITH MEMORY, BRAIN FOG, RECOGNIZING AND KNOWING THE NAME FOR EVERYDAY HOUSEHOLD ITEMS, TINNITUS, CONFUSION AND TREMORS. AT ONE POINT I WAS HAVING AUDITORY HALLUCINATIONS.