IBRAIN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for IBRAIN manufactured by Neurovigil, Brain Decoding Company.

Event Text Entries

[177546906] Product was used during a major operation, and was not medically major damage. Device is malfunctioning and the (b)(6) medical board has failed to investigate. Info is contained in confidential medical records, as well as confidential police records ((b)(6)). Civil attorney discussed info in police records with federal magistrate in central district court. Was done without my consent or counseling on possible future medical complications, and i am being slandered to hide the fact that it was done. Family members may have received compensation, but never divulged this info to me. This product is a medical device, cutting edge single channel eeg recording tool, with wireless connectors calibrated to a computer for analysis, but also to a cell phone if desired. A miniature electrode for transmission and receiving was implanted without my authorization. Now this device has been hipaa complaint, but when i had my operation, it was not. I was falsely arrested by (b)(6) when i was requesting investigations into this device being implanted, by law enforcement officers practicing misconduct. My ex-girlfriend was dating a cop and this info was divulged to her, and she disclosed this info to my family. A huge sum of money was deposited into my credit union account during my civil litigation (pending, 1 yr in court), and i was locked out of my account on-line. Automated system revenged transaction and transfer of funds to another account. I had a supv fax me the info to the transaction and provided the info to my attorney, that had been contacted by my family members without my knowledge. He did not divulge this info to the district attorney,(b)(6) city attorney, nor the magistrate, but this was the crux of my false arrest, malicious prosecution, and two detectives falsifying evidence, prior to my acquittal. (b)(6), and does 1-10 inclusive; i am suffering from severe nerve damage because when i sleep i get electrical shocks from the calibrated electrode transmitting data for analysis. Other times, i get shocks because the individuals that received money for this, are tormenting me for requesting investigation into this, but broadcasting on a dark web site, what they are doing. Not sure of the name civil attorney refused to relinquish file, judge ordered a gag. Device malfunctioning began around 2017 with many visits to a dr or hosp medical complications were conducted as unk, possible crohn's complications. Operation for crohn's disease was performed on (b)(6) 2009 at (b)(6) medical center, but product has no significance to condition. Was done for experimental purposes and medical research and study. Unaware of who controls the device, but data is wirelessly transmitted to (b)(6) for analysis. Psychologically traumatized by sedation, and family is broadcasting capabilities from product, for profit.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092674
MDR Report Key9654310
Date Received2020-01-30
Date of Report2020-01-21
Date of Event2019-06-06
Date Added to Maude2020-01-31
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 Report3

Device Details

Brand NameIBRAIN
Generic NameFULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH
Product CodeGWQ
Date Received2020-01-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerNEUROVIGIL, BRAIN DECODING COMPANY


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Deathisabilit 2020-01-30

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