FDA Adverse Event Injury Summary report: N

LOW ENERGY NEUROFEEDBACK SYSTEM

MDR report key: 3770966 · Received April 21, 2014

Report

Report Number
MW5035757
Event Type
Injury
Date Received
April 21, 2014
Date of Event
September 30, 2006
Report Date
April 19, 2014
Manufacturer
OCH LABS
Product Code
HCC
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I AM WRITING TO YOU REGARDING AN INCIDENT THAT OCCURRED ON (B)(6), 2006 BETWEEN THE HOURS OF TWO P.M. AND FOUR P.M. AT APPROXIMATELY 2 P.M., I WAS TRANSPORTED FROM A PSYCHOLOGIST'S OFFICE, BY AMBULANCE TO AN EMERGENCY ROOM BECAUSE I WAS EXPERIENCING WEAKNESS AND NUMBNESS IN MY LEGS AFTER HAVING AN EEG BIOFEEDBACK TREATMENT ON MY BRAIN. THE NAME OF THE NEUROTHERAPY DEVICE IS CALLED LOW ENERGY NEUROTHERAPY SYSTEMS, AND WAS INVENTED BY (B)(6). I WAS BEING TREATED FOR MEMORY PROBLEMS RELATED TO A CAR ACCIDENT THAT I HAD A FEW YEARS EARLIER. IMMEDIATELY AFTER THE NEUROTHERAPY, I EXPERIENCED GREAT DIFFICULTY WALKING. I HAD PROBLEMS BALANCING MYSELF AND COULD NOT STAND UP BECAUSE I WAS HAVING TREMORS AND MUSCLE SPASMS IN MY LEGS. THE PSYCHOLOGIST WHO ADMINISTERED THE EEG TREATMENT APPROXIMATELY ONE HALF HOUR EARLIER STATED THAT IF I WENT TO THE EMERGENCY ROOM. I WOULD BE GIVEN MEDICATION TO STOP THE TREMORS AND MUSCLE SPASMS IN MY LEGS, SO THAT IS WHAT I DID. THE PSYCHOLOGIST WHO ADMINISTERS THE BIOFEEDBACK GAVE THE AMBULANCE DRIVER HIS BUSINESS CARD TO GIVE TO THE EMERGENCY ROOM PHYSICIAN. WHEN I GOT TO THE HOSPITAL, I COULDN'T WALK, SO I HAD TO HOLD ONTO THE WALLS OF THE ROOM I WAS IN. AFTER THIS INCIDENT, I HAD PROBLEMS SLEEPING, VISUAL DISTURBANCES, AND RAPID UNCONTROLLABLE EYE BLINKING. THE VISUAL DISTURBANCES MADE OBJECTS LOOK LARGER AND OUT OF PROPORTION. I ALSO BECAME VERY SENSITIVE TO LIGHT. THESE ADVERSE EFFECTS WENT ON FOR MONTHS AFTER THE TREATMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
241725 LOW ENERGY NEUROFEEDBACK SYSTEM LOW ENERGY NEUROFEEDBACK SYSTEM HCC OCH LABS

Patients

Seq Age Sex Outcome Treatment
1 46 YR Required Intervention