MAUDE Adverse Event Report: OCH LABS LOW ENERGY NEUROFEEDBACK SYSTEM

Device Problem Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Visual Disturbances (2140); Weakness (2145); Blinking, Excessive (2229); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 09/30/2006

Event Type  Injury  

Event Description

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.

• Brand Name: LOW ENERGY NEUROFEEDBACK SYSTEM
• Type of Device: LOW ENERGY NEUROFEEDBACK SYSTEM
• Manufacturer (Section D): OCH LABS
• MDR Report Key: 3770966
• MDR Text Key: 20294961
• Report Number: MW5035757
• Device Sequence Number: 1
• Product Code: HCC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 91