LOW ENERGY NEUROFEEDBACK SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-21 for LOW ENERGY NEUROFEEDBACK SYSTEM manufactured by Och Labs.

Event Text Entries

[20294961] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5035757
MDR Report Key3770966
Date Received2014-04-21
Date of Report2014-04-19
Date of Event2006-09-30
Date Added to Maude2014-04-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLOW ENERGY NEUROFEEDBACK SYSTEM
Generic NameLOW ENERGY NEUROFEEDBACK SYSTEM
Product CodeHCC
Date Received2014-04-21
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerOCH LABS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-04-21

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