inforMED
InjuryHCC

CYGNET NEUROFEEDBACK SYSTEM

Received Oct 11, 2024 · Event occurred Oct 10, 2023

Report MW5161046 · MDR key 20453150

Device

Generic name

Device, Biofeedback

Manufacturer

Unk

Patient

44 YR · Female

  • Tinnitus
  • Anxiety
  • Sleep Dysfunction
  • Unspecified Mental, Emotional or Behavioural Problem
  • Tinnitus
  • Anxiety
  • Sleep Dysfunction
  • Unspecified Mental, Emotional or Behavioural Problem

Narrative

Description of Event or Problem

I EXPERIENCED SIDE EFFECTS FROM NEUROFEEDBACK TREATMENT. I WAS EXPERIENCING SLEEP ISSUES AND SOME ANXIETY DUE TO A STRESSOR. THE ANXIETY WASN'T TOO MUCH AND I WAS ABLE TO STAY CALM AND HANDLE IT. I WAS WORRIED ABOUT A SITUATION HOWEVER THE SITUATION RESOLVED AND I MAINLY DID THE NEUROFEEDBACK TREATMENT TO HELP ME WITH THE SLEEP ISSUE. I STARTED EXPERIENCING EXTREME ANXIETY AFTER THE 3RD SESSION. WOKE UP IN THE MIDDLE OF THE NIGHT WITH EXTREME ANXIETY, TINNITUS, INTRUSIVE THOUGHTS AND HAD TO GO TO THE HOSPITAL. I WAS NOT ABLE TO CALM MYSELF FOR DAYS AND DOCTOR PRESCRIBED ME ANTI ANXIETY MEDS TO CALM MYSELF. I HAVE SINCE BEEN DIAGNOSED WITH GENERALIZED ANXIETY DISORDER. IT HAS BEEN ONE YEAR AND I STILL EXPERIENCE TINNITUS.