NEUROINTEGRATOR 2 AMPLIFIER/PHOTOSONIX PHOTICSTIMULATION GLASSES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-09 for NEUROINTEGRATOR 2 AMPLIFIER/PHOTOSONIX PHOTICSTIMULATION GLASSES manufactured by Clear Mind Center/photosonix.

Event Text Entries

[40250069] Required primary care physician office visit, neurologist office visit, naturopath office visit, counseling for ptsd. I am writing to file a complaint against (b)(6). This company markets "the complete professional neurofeedback system" (also referred to as the "clear mind neurofeedback system") nationally, for $(b)(6), to various health care professionals, enabling them to administer neurofeedback therapy to - and increase their revenue from - their already established client base ((b)(6)). On (b)(6) 2014, i suffered a severe adverse reaction during a neurofeedback session conducted by (b)(6), lpt, under the supervision of his wife, dr. (b)(6), at (b)(6), located at (b)(6). Based on the results from an interview, questionnaire, and a "brain mini-mapping," i was informed that i was a "suitable candidate" to benefit from the "unique" neurointegrator2 protocol, which involves the use of a "neurointegrator2 amplifier" in conjunction with "photic stimulation glasses," (products included in "the complete professional neurofeedback system," sold by (b)(6). ) before committing to the recommended pre-paid treatment plan of 22 sessions, i participated in an introductory session, administered by mr. (b)(6) under dr. (b)(6) supervision. As soon as i sat down in front of the neurointegrator2 amplifier, i felt the back of my neck become stiff and aching and my heart began to "race," which i thought odd, but elected to proceed as i had been assured that the therapy was "completely safe and non-invasive. " almost immediately after leaving their office after the session ended, however, i began to experience extremely disturbing symptoms, similar to those of "pre-seizure"/"post-concussion" that are common with traumatic brain injuries. I also felt inexplicably "emotional," bordering on a feeling of "hysteria. " it was obvious that something had gone terribly wrong as a result of the session. In my traumatized state, i suppressed my immediate urge to go to the hospital emergency room because i was terrified that i would be subjected to further emf technology such as a diagnostic cat-scan or mri. (i was later informed by my primary care physician and neurologist that the damage i suffered would not show up on these types of scans anyway). Over the course of the next five months, my life became a living nightmare as i experienced a wide range of disabling symptoms, including: fatigue, photo-sensitivity, anxiety, feeling on the verge of tears, difficulty performing daily tasks, eyes tiring easily as well as visual disturbances (floaters and flashing lights), acute tension headaches, dizziness and light-headedness, feelings of dissociation, brain "fog," pressure headaches, inability to concentrate, feelings of sadness and listlessness, frustration, impaired decision-making, easily irritated, inability to focus, feeling easily overwhelmed, increased sensitivity to sounds and distractions, feeling "detached," "spacy," "fuzzy," "strange," and disoriented. I was forced to cancel all of my normal activities and summer travel plans (including two pre-paid summer concerts, three planned vacations and a family reunion,) previously scheduled dental work, and all social engagements. For the first two months, i remained at home, wearing dark sunglasses, with extremely limited use of the computer and television. This prevented me from engaging in my daily writing activities as a free-lance screenwriter. I also experienced debilitating post-traumatic stress as a result of the invasive nature of the electro-magnetic waves which penetrated my eyes and brain, inflicting both physiological and phycological harm. This lasted for approximately five months in its most severe form, and prevented me from even being able to discuss the traumatic event with my therapist until months later. I am still receiving counseling related to this incident. In order to obtain and explantation as to what could have possibly caused such a reaction, i consulted with my primary care physician, a neurologist, a naturopathic doctor, a psychotherapist trained in ptsd, and an internationally-renowned expert in neurofeedback. The general consensus was that i had apparently suffered "hyperstimulation" of my brain, inducing brain wave instability and a "pre-seizure" state. I was advised to follow the course of treatment for a concussion.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060836
MDR Report Key5495300
Date Received2016-03-09
Date of Report2016-02-25
Date of Event2014-07-18
Date Added to Maude2016-03-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNEUROINTEGRATOR 2 AMPLIFIER/PHOTOSONIX PHOTICSTIMULATION GLASSES
Generic NameNEUROINTEGRATOR 2 AMPLIFIER/PHOTOSONIX PHOTICSTIMULATION GLASSES
Product CodeHCC
Date Received2016-03-09
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCLEAR MIND CENTER/PHOTOSONIX


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-03-09

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