MAUDE Adverse Event Report: NEUROPTIMAL ADVANCED BRAIN TRAINING SYSTEM; DEVICE, BIOFEEDBACK

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

Patient Problems Brain Injury (2219); Reaction (2414); Confusion/ Disorientation (2553)

Event Date 06/20/2019

Event Type  Injury  

Event Description

The consumer is concerned because the product advertises that there are no side effects.The consumer is also concerned that frequent use of the product can cause permanent damage to the brain.The consumer had a treatment at a psychotherapist's office on (b)(6) 2019.After one treatment the consumer had an adverse reaction.The consumer stated that she felt lightheaded, foggy and spacey two days afterwards.Zengar.(b)(4).

• Brand Name: NEUROPTIMAL ADVANCED BRAIN TRAINING SYSTEM
• Type of Device: DEVICE, BIOFEEDBACK
• MDR Report Key: 8794724
• MDR Text Key: 151588699
• Report Number: MW5088180
• 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: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1