MAUDE MDR 5471114

MDR report key
5471114
Report number
MW5060633
Event key
0
Event type
3
Date of event
2014-08-05
Date received
2016-02-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOFEEDBACK DEVICEBIOFEEDBACK DEVICEOCHSLABSHCC* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-2601. S

Event Narratives#

D

Patient 1

ON (B)(6) 2014, I WENT TO (B)(6) TO HAVE A LENS (LOW ENERGY NEUROFEEDBACK SESSION). SHE WAS IMPROPERLY TRAINED, USED IT INCORRECTLY AND I HAVE HAD SEVERE TINNITUS 24/7 EVER SINCE. I SPOKE TO OTHER LENS PRACTITIONERS AND THEY SAID (B)(6) SHOULD HAVE USED ONLY 2-3 POINTS SINCE I WAS A FIRST TIME CUSTOMER. (B)(6) USED ALL 21 POINTS. THE THERAPISTS I TALKED TO SAID THAT NEVER SHOULD HAVE BEEN DONE. I CONTACTED HER 2 DAYS LATER (SEE EMAILS BELOW). I FILED IN SMALL CLAIMS COURT, (B)(6). THE SHERIFF TOLD ME THAT (B)(6) HAD LEFT THE STATE. ONE THERAPIST I CONTACTED SAID SHE HAD SEEN SEVERAL OF (B)(6) CLIENTS BECAUSE THEY WERE DISSATISFIED. I DO NOT KNOW THE EXTENT OF THEIR PROBLEMS. I HAVE PURCHASED ITEMS TO TRY TO GET RID OF TINNITUS. I CONTACTED (B)(6) WHO CREATED THE LENS AND TOLD THEM WHAT HAPPENED. THEY SAID; "I UNFORTUNATELY HAVE NO THOUGHTS OR ASSISTANCE TO OFFER YOU AS WE, A BIOFEEDBACK COMPANY AND NOT A MEDICAL COMPANY, ASSEMBLE HARDWARE AND SOFTWARE." HOWEVER, THEY PROVIDE THE TRAINING FOR THE LENS SYSTEM. I FILLED OUT A REPORT WITH THE (B)(6). THEY SAID IT WASN'T UNDER THEIR JURISDICTION. I HAVE SPENT $(B)(6) TRYING TO CURE WHAT (B)(6) AND LENS DID TO ME. NOTHING HAS HELPED. I HAVE A RECORD OF ALL MY COMMUNICATIONS. MY INITIAL COMMUNICATION AFTER THE APPOINTMENT WITH (B)(6) FOLLOWS: ON (B)(6) 2014: (B)(6), THIS IS NOW GOING ON 11 DAYS. I CAN BARELY HEAR OUT OF MY RIGHT EAR BECAUSE OF THE TINNITUS PROBLEM CREATED BY THE LENS SESSION. IT IS AFFECTING MY WHOLE LIFE. YOU SAID IT MAY BE A CASE OF "IT GETS WORSE BEFORE IT GETS BETTER". I DIDN'T HAVE TINNITUS BEFORE THE SESSION. I PAID FOR ANOTHER LENS SESSION HERE IN (B)(6) TO SEE IF IT COULD CORRECT WHAT WAS DONE TO ME BUT IT DIDN'T HELP. I HAVE ALSO TRIED THE SALT SPA WHICH HELPS WITH CILIA. THAT ALSO DID NOTHING. ONE THING THE THERAPIST DID SAY WAS THAT SOMEONE AS SENSITIVE AS I AM SHOULD NEVER HAVE HAD 21 POINTS WORKED ON. THEY ONLY WORKED ON 7. I THINK WE NEED TO TALK TO SEE WHAT TO DO ABOUT THIS. I DO NOT FEEL I SHOULD HAVE TO PAY TO CORRECT A PROBLEM THAT WAS CREATED BY THIS SESSION. MY PHONE# IS (B)(6). I LOOK FORWARD TO HEARING FROM YOU. (B)(6). ORIGINAL MESSAGE FROM: >(B)(6)> TO "(B)(6)> SUBJECT: RE: TUESDAY'S SESSION, DATE: (B)(6) 2014 09:28:06 - 0700 - HI (B)(6) , THANKS FOR WRITING WITH AN UPDATE. I APPRECIATE IT. THERE ARE A FEW OPTIONS WITH THE TINNITUS, FIRST: TO RECEIVE ADD'L TREATMENTS WITH LENS IN ORDER TO HELP SMOOTH OUT THIS REACTION OVER TIME. AS I MENTIONED IT CAN SOMETIMES HAPPEN WITH THE LENS TREATMENT, THIS MAY BE A CASE OF "IT GETS WORSE BEFORE IT GETS BETTER". SECOND, IS TO WAIT IT OUT AND SEE IF IT CALMS ITSELF DOWN AND GOES AWAY. THIRD, TO SCHEDULE A SESSION OF "NEUROPTIMAL" NEUROFEEDBACK, WHICH HAS A CALMING EFFECT ON THE CENTRAL SYSTEM. THIS HAS BEEN KNOWN TO REDUCE AND CALM DOWN THE BRAIN AFTER HYPER STIMULATION FROM LENS. I BELIEVE THIS IS THE TREATMENT YOUR FRIEND RECEIVED. I CAN REFER YOU TO A CLINIC CALLED (B)(6) THAT WOULD BE HAPPY TO SCHEDULE WITH YOU. IF YOU MENTION YOU CAME FROM THE (B)(6), THEY WILL LIKELY BOOK THE SESSION FOR $(B)(6). PLEASE LET ME KNOW WHAT YOU WOULD LIKE TO DO. THAN YOU VERY MUCH, (B)(6). ON (B)(6) 2014: (B)(6), MY SESSION ON TUESDAY WAS VERY INTERESTING. YOU SAID IT MAY TAKE 24 HOURS TO NOTICE ANYTHING. THE ONE THING I HAVE NOTICED IS TINNITUS WHEREAS, I HAD JUST A SLIGHT TOUCH OF IT AND IT WAS SPORADIC, I NOW NOTICE IT IN MY RIGHT EAR 24/7. AND IT IS MUCH LOUDER THAN IT WAS BEFORE. DO YOU KNOW OF ANYTHING I CAN DO TO REVERSE THIS? THANKS (B)(6).