MAUDE Adverse Event Report: NEUROPTIMAL 3; DEVICE, BIOFEEDBACK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anxiety (2328); Sleep Dysfunction (2517)

Event Date 03/27/2019

Event Type  Injury  

Event Description

I used neuroptimal's neurofeedback device for a single 40 min session on the afternoon of (b)(6) 2019.To date the device, you hook electrodes to your ears and a couple of spots on your scalp.The electrodes are connected to an (b)(6)-like tablet that reads your brain waves and plays music.The music pauses very briefly when the device detects your brain is not performing in an "optimal way." this is supposed to train your brain to be more efficient and improve concentration etc.Since using the neuroptimal device, i have not slept more than 2 1/2 to 3 hours of sleep every night.The sleep i have gotten has been in broken, non-connected hours.I'll fall asleep for an hour, wake up, stay awake for hours, then fall asleep again for another hour, if that.Last night i was only able to sleep for one hour.I am not able to take naps during the day.Insomnia is not a problem i have ever had before.I've also noticed significant social anxiety since using the device which consists of a pounding heart and a fight/flight response when in a crowd.This is also not a problem i have ever had before.The neuroptimal company website specifically says that there are no side effects from using their machine.Fda safety report id# (b)(4).

• Brand Name: NEUROPTIMAL 3
• Type of Device: DEVICE, BIOFEEDBACK
• MDR Report Key: 8483247
• MDR Text Key: 141176439
• Report Number: MW5085594
• Device Sequence Number: 1
• Product Code: HCC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 37 YR
• Patient Weight: 70