BRAIN ENTRAINMENT SOFTWARE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for BRAIN ENTRAINMENT SOFTWARE manufactured by Braincore.

Event Text Entries

[69143462] After undergoing 20 neurofeedback sessions with a practitioner who supplied braincore software, and seeing no positive improvements. I was told that a "protocol" change was necessary. In the sessions that followed (specifically, 3 sessions, it was clear that my overall health was becoming worse. I ended the treatment sessions, but the problems have not subsided after one month. Slower thinking occasional inability to think "flashes" of clinical depression, a "magnetizing" effect when i look at screens, inability to "feel good" (most likely due to reduced physiological arousal), and an onset of ocd symptoms. I have never experienced these symptoms before in my life, and from what i've read post treatment, they may be long-term. Already, though i may be dropping my second-semester college courses, after finishing my first college year with a's and b's because i cannot preform like i used to in class. I am emotionally and physically hurt. It's hard to place a clear blame on what did this to me, but overall, the main problem is that consumers are not being adequately informed about potential risks. "why most likely," because health impairments from neurofeedback are usually very rare. However, "rare" does not mean harmless. After searching various neurology forums for answers, i have come to the conclusion that i now belong to a small minority of people who have been harmed by undergoing neurofeedback in various ways, but always severely. Three have apparently tried to sue the establishments that supplied the therapy, but two lacked the knowledge to sue and one was apparently counter sued by a large neurofeedback group. Most stay quiet. In my case, the practitioner i went to is treating lots of client with this therapy, and it almost seems morally wrong to attempt to sue them. (implying i have the resources to sue, which i don't. ) they were also bcia-certified. "to what extent," who knows. That's another issue. It's incredibly difficult to tell a competent practitioner from an incompetent one, seeing as they all have good reviews, until they hook you up. Also, corporations like braincore are claiming to treat a variety of disabilities as a "side effect free" substitute for medication. This is usually the treatment that reels people in expecting their problems to be alleviated. Sometimes, they are! But sometimes, they aren't and sometimes, it makes everything so much worse with no end in sight. But everywhere you look, you hear the same thing. "no side effects, proven by studies" with a little disclaimer that people tend to ignore about not being considered a "cure" for anything. These are two layers of public danger. In fact, the danger is worse than side-effects from medication because you cannot simply "fet off of it" to make the effects subside. I am speaking to the fda here because, despite how difficult is to hold someone responsible, an average person out there, right now, can be enticed into taking neurofeedback for their issues, and they can end up mentally damaged with few sources to seek help from. Like me, at least, a "warning label" of sorts should be made publicly known that reference the "small minority" of people that have suffered serious harm from neurofeedback. Usually, medications include clear warnings for people with certain conditions that could react negatively with the medication. However, in the case of neurofeedback, it currently seems impossible to tell if someone will be harmed by it until they try it and regret everything. Bottom line; it's not necessarily a "drug", but it's being sold like medicine to people. And the side-effects from this "medicine" can be devastating for various reasons. Regardless of who's to blame, something must be done to protect that one unlucky consumer from rampant misinformation and lifelong regret, i don't want a lawsuit, i want the possible side-effects of modern neurofeedback investigated and publicized. People out there are getting hurt by a lack of info.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5068216
MDR Report Key6375764
Date Received2017-03-01
Date of Report2017-03-01
Date of Event2017-01-21
Date Added to Maude2017-03-03
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 NameBRAIN ENTRAINMENT SOFTWARE
Generic NameBIOFEEDBACK/NEUROFEEDBACK
Product CodeHCC
Date Received2017-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBRAINCORE


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2017-03-01

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