inforMED
InjuryHCC

BRAINCORE SYSTEMS

Received Nov 23, 2022 · Event occurred Mar 6, 2022

Report MW5113463 · MDR key 15864826

Device

Generic name

Device, Biofeedback

Product problems

  • Patient Device Interaction Problem

Patient

47 YR · Male

  • Brain Injury
  • Shaking/Tremors
  • Brain Injury
  • Shaking/Tremors

Narrative

Description of Event or Problem

I SUFFERED AN INJURY FROM DR (B)(6) A CHIROPRACTOR USING BRAINCORE SYSTEMS FOR MENTAL HEALTH. BRAINCORE BIOFEEDBACK/NEUROFEEDBACK IS LED BY CHIROPRACTORS WHO MARKET AS NO SIDE EFFECTS. I HAVE 24/7 TREMORS AS A RESULT OF THE PRODUCT. BRAINCORE IS DOMICILED IN (B)(6). THEY DO NOT HAVE A 510K STATUS. I HAVE SEVERE ABNORMAL EEGS. OSCILLATIONS OF 1 HERTZ THROUGHOUT THE BRAIN. THE SYSTEM SHOWED CONSTANT IMPROVEMENT AND I ENDED UP WITH SERIOUS INJURY. BRAINCORE OWNERS HAVE NOT HELPED ME. I FILED A COMPLAINT WITH MA /FDA. THIS SYSTEM IS A PUBLIC HEALTH AND SAFETY RISK. CHIROPRACTORS MARKET IT AND THEN LEAVE THE ROOM DURING SESSIONS. IF THE PROTOCOLS ARE INCORRECT AND NOT MONITORED BY THE CHIROPRACTORS, THERE ARE SIGNIFICANT CONSEQUENCES. MANY OTHER COMPETENT NEUROFEEDBACK DOCTORS CONDONE BRAINCORE FOR EXAGGERATED CLAIMS. THE EXACT DATE NOT MARCH 6TH. TREATMENT DECLINE WAS OVER LONGER PERIOD RESULTING IN INJURY DURING MANY ALPHA/THETA TRAINING RESULTING IN LOW ALPHA AND INCREASED BETA. I HAVE SENT BRAINCORE A CERTIFIED LETTER EXPLAINING MY INJURY. I DON'T EXPECT A RESPONSE. SOFTWARE DATA NEWMINSMAP.COM. FDA SAFETY REPORT ID# (B)(4).

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 11/30/2022 FOR REPORT MW5113463. "IS NEWMINDMAPS TECHNOLOGY REGISTERED WITH FDA. THEY DEVELOP SOFTWARE AND BRAINCORE PRIVATE LABELS IT FOR QEEG." I CONTACTED OWNER TO SEE IF HE WOULD HELP ME WITH BRAINCORE INJURY SINCE THEY DEVELOP SOFTWARE.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 12/20/2022 FOR REPORT MW5113463.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 02/16/2023 FOR REPORT MW5113463.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 03/02/2023 FOR MW5113463. REPORTER CALLING STATING THAT HIS SYMPTOMS CONTINUE. HE STATES THAT HE HAS PREVIOUSLY CONTACTED THE DEVICE MAKER AND THEY HAVE BEEN UNHELPFUL. REPORTER STATES HE HAS CONTINUED CONCERNS THAT THIS DEVICE IS NOT FDA APPROVED.