VIDEONYSTAGMOGRAPHY
Received Nov 12, 2019 · Event occurred Jul 9, 2018
Report MW5091030 · MDR key 9316884
Device
Generic name
Nystagmograph
Manufacturer
Secure Health Inc. / S. A. Instrumentation DifraProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR
- Hearing Impairment
- Pain
- Visual Impairment
- Hearing Impairment
- Pain
- Visual Impairment
Narrative
Description of Event or Problem
I WAS GIVEN VNG TEST FOR VESTIBULAR PROBLEMS. WHEN AWAKENED IN AM EVERYTHING LOOKED CLOUDY. CALLED PERSON WHOM GAVE TEST BUT HE REFUSED TO TALK TO ME SAYING THAT WAS NOT POSSIBLE. WENT TO MY OPHTHALMOLOGIST, WITHIN A WEEK TO SEE IF RETINA BURNED OR WHATEVER HAPPENED TO ALMOST PERFECT EYES. LEFT EYE WAS BEST EYE AT ABOUT 20/25 AND IT WAS THE MOST AFFECTED AS TIME PASSED. OPHTHALMOLOGIST SAID I NEEDED TO HAVE CATARACTS REMOVED, A YEAR EARLIER HE SAID I WAS ABOUT 5 YEARS OUT. MY RIGHT EYE BECAME THE EYE THAT I RELIED UPON AND NOW IT IS CLOUDING OVER. I HAD HOPED TO WAIT TILL (B)(6) TO REMOVE THEM BUT NOW HAVE TO GET IT DONE. I HAVE PROOF FROM AN EYE SPECIALIST THAT MY EYESIGHT WAS GREAT FROM ABOUT 5 MONTHS PRIOR TO THE VNG. I FEEL SURE THAT THIS IS NOT FIRST TIME THIS PROBLEM HAS SURFACED, SO I FELT COMPELLED TO SEND THIS TO PERHAPS HELP OTHERS. THE TEST WAS PAINFUL AND FELT AS THOUGH IT WAS HURTING MY HEARING RATHER THAN HELPING DIAGNOSE BALANCE ISSUES. NEEDLESS TO SAY I WAS NEVER EVEN GIVEN RESULTS OF THIS DAMAGING TEST. PERHAPS THE GOOGLES IN THE DARK AND THE TESTER CONSTANTLY SAYING DON'T CLOSE YOUR EYES TO INFRARED LIGHT IN THEM PLAYED A PART. PERHAPS IT DRIED OUT THE CORNEA CAUSING THE BAD EYESIGHT. IT NEEDS TO BE LOOKED INTO. I NOW RESTRICT MY DRIVING TILL SURGERY FROM PERFECT EYESIGHT. JUST SAYING. WIN WIN. FDA SAFETY REPORT ID# (B)(4).