inforMED
InjuryOKP

STMS MINI

Received Aug 9, 2019 · Event occurred Jul 17, 2019

Report 3008487930-2019-00001 · MDR key 8879917

Device

Generic name

Transcranial Magnetic Stimulator

Manufacturer

Eneura, Inc.

Model number

DWG-0500

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Foreign Body Sensation in Eye
  • Headache
  • Tingling
  • Anxiety
  • Ambulation or Postural Difficulties
  • Cognitive Changes
  • Confusion/ Disorientation
  • Foreign Body Sensation in Eye
  • Headache
  • Tingling
  • Anxiety
  • Ambulation or Postural Difficulties
  • Cognitive Changes
  • Confusion/ Disorientation

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT BEGAN TREATMENT OF HER CHRONIC HEMIPLEGIC MIGRAINES WITH THE STMS MINI ON (B)(6) 2019 AND DELIVERED TWO "CLICKS" AS DIRECTED IN THE WRITTEN INSTRUCTIONS AND AS PRESCRIBED BY HER DOCTOR. PRIOR TO USING THE STMS MINI, THE PATIENT WAS FEELING WELL WITH NO SYMPTOMS OF MIGRAINE. AFTER THE FIRST CLICK, THE PATIENT HAD A SENSATION OF SOMETHING ODD HAPPENING IN HER BRAIN. IMMEDIATELY AFTER THE SECOND CLICK, SHE BEGAN TO HAVE THE USUAL SYMPTOMS THAT OCCUR WITH HER MORE SEVERE MIGRAINES: SIGNIFICANT FACIAL SAGGING, EXTREME DROOPING OF HER RIGHT EYELID, TINGLING IN HER RIGHT ARMA ND HAND, ANXIETY, CONFUSION. ADDITIONALLY SHE REPORTED A SENSATION THAT SOMETHING WAS "WRONG" IN HER BRAIN. WITHIN 10 MINUTES, SHE WAS HAVING A FULL BLOWN MIGRAINE ALONG WITH AN UNUSUAL PRESSURE SENSATION AROUND THE TOP OF HER HEAD. IT WAS UNUSUAL FOR HER TO FEEL PRESSURE AROUND HER WHOLE HEAD INSTEAD OF ONLY ON THE RIGHT SIDE. HER COGNITIVE FUNCTION WORSENED, SHE HAD EXTREME DROOPING OF HER RIGHT EYE. WHEN SHE TRIED TO STAND UP, SHE WAS VERY UNSTEADY AND REQUIRED ASSISTANCE TO WALK FROM A CHAIR TO HER BED. SHE DESCRIBED THE EVENT AS THE WORST MIGRAINE SHE HAS HAD WITH THE ADDITIONAL SYMPTOM OF THE PRESSURE IN HER UPPER HEAD. WITHIN A FEW HOURS, THE PRESSURE LESSENED SOMEWHAT BUT HER ACTIVITIES AND ABILITY TO FUNCTION NORMALLY ARE STILL IMPAIRED. SHE CONTACTED THE DOCTOR'S OFFICE AND THE NURSE FROM ENEURA ABOUT THE PROBLEM.