NEUROPTIMAL 3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for NEUROPTIMAL 3 manufactured by Unk.

Event Text Entries

[141176439] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085594
MDR Report Key8483247
Date Received2019-04-03
Date of Report2019-04-01
Date of Event2019-03-27
Date Added to Maude2019-04-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNEUROPTIMAL 3
Generic NameDEVICE, BIOFEEDBACK
Product CodeHCC
Date Received2019-04-03
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-04-03

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