FDA Adverse Event
Injury
Summary report: N
NEUROFEEDBACK EEG
MDR report key: 20560634
·
Received October 28, 2024
Report
- Report Number
- MW5161803
- Event Type
- Injury
- Date Received
- October 28, 2024
- Date of Event
- August 22, 2022
- Report Date
- October 5, 2024
- Manufacturer
- BRAINMASTER TECHNOLOGIES, INC
- Product Code
- HCC
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
I DID NEUROFEEDBACK AT (B)(6) BACK IN 2022, NEVER HAD I HAD THESE SYMPTOMS BEFORE NEUROFEEDBACK. MY SYMPTOMS INCLUDE BUT ARE NOT LIMITED TO 2 YEARS OUT-WORSENED DEPRESSION, MEMORY LOSS, CHRONIC INSOMNIA, MUSCLE WEAKNESS, EXERCISE INTOLERANCE, TREMORS, NUMBNESS, TINGLING, HORMONE ISSUES, ATTENTION PROBLEMS, INABILITY TO REGULATE BODY TEMPERATURE, EXHAUSTION WITH THE MOST MINIMAL EFFORT, FEELING DISCONNECTED, LOSS OF EXECUTIVE FUNCTION, LOSS OF ORGANIZATION, INABILITY TO LEARN NEW INFORMATION, GUT ISSUES, INFLAMMATION, MEMORY ISSUES BOTH LONG AND SHORT TERM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1982024 | NEUROFEEDBACK EEG | DEVICE, BIOFEEDBACK | HCC | BRAINMASTER TECHNOLOGIES, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Disability| R| L| H | 20 MG ADDERALL TWICE DAILY.| CLONIDINE 1MG.| FISH OIL.| GABAPENTIN 1200 MG.| LIOTHYRONINE SOD 5 MCG TAB.| MAGNESIUM.| TEMAZEPAM 30 MG. | ZYPREXA 10MG. |