Description of Event or Problem · 1
RE: VAGUS NERVE STIMULATOR IMPLANTATION, 2000; SCHEDULED AGAIN FOR (B)(6) 2012. TO THOSE WHOM IT MAY CONCERN: FIRST, I WOULD LIKE TO TELL YOU MY STORY. IN 1994, I WAS DIAGNOSED WITH SEVERE DEPRESSION. FOR FIVE YEARS, I MUST HAVE TRIED TEN DIFFERENT MEDICATIONS AND FOUR OR FIVE LOCAL PSYCHIATRISTS. NONE OF THESE DOCTORS OR MEDICATIONS WERE ABLE TO HELP ME EVEN BEGIN THE ROAD TO WELLNESS. FINALLY, ON MY OWN, AND WITH MY LAST VESTIGE OF ENERGY, DETERMINATION AND HOPE, I SOUGHT OUT A CONSULTATION WITH (B)(6), M.D. AT THE (B)(6). UNLIKE OTHER PSYCHIATRISTS, DR. (B)(6) TRIED COMBINING SEVERAL TYPES OF MEDICATIONS, WHICH SEEMED TO HELP SOMEWHAT. FINALLY, HOWEVER, HE RECOMMENDED THAT I BECOME PART OF A MEDICAL STUDY HE WAS DIRECTING FOR CYBERONICS, INC. TO STUDY THE VAGUS NERVE STIMULATOR. IT TOOK A GREAT DEAL OF COURAGE, BUT, WITH ONE FINAL OUNCE OF ENERGY AND LIFE, I VOLUNTEERED AND ENTRUSTED MY BODY AND MIND TO CYBERONICS TO IMPLANT A METAL PACEMAKER DEVICE IN MY CHEST. AFTER ALL I HAD BEEN THROUGH WITH DEPRESSION, I HAD JUST ABOUT GIVEN UP HOPE IN MY STRUGGLE TO LIVE. NO LONGER CARING ABOUT WHAT WOULD HAPPEN TO ME, I ACCEPTED THE TRIAL OF A NON-FDA APPROVED DEVICE IN HOPES THAT, EVEN IF THE VNS DEVICE DID NOT HELP ME, THROUGH CYBERONICS I COULD AT LEAST CONTRIBUTE TO THE SCIENCE OF MEDICINE AND, MAYBE, HELP OTHER SEVERELY DEPRESSED INDIVIDUALS WHO WERE ALSO STRUGGLING FOR THEIR LIVES. EVEN HELPING ONE PERSON WOULD BE A TRIUMPH! AS PART OF THE MEDICAL STUDY, I WAS IMPLANTED AT (B)(6) IN (B)(6) 2000. THE FIRST YEAR OF IMPLANTATION WAS ANOTHER STRUGGLE BUT WELL WORTH THE EFFORT. THE ENTIRE STUDY WAS A HUGE COMMITMENT FOR ME. LIVING IN (B)(6) PERMANENTLY, I MADE ARRANGEMENTS TO FIND AN APARTMENT IN (B)(6) FOR TWO MONTHS FOR THE DOCTORS' INTENSIVE MONITORING OF THE VNS DEVICE. AFTER THOSE FIRST MONTHS, I RETURNED TO (B)(6) AND FLEW TO (B)(6) EVERY TWO WEEKS, THEN ONCE A MONTH UNTIL THE STUDY ENDED. AT THAT TIME, (B)(6) , M.D. AT (B)(6) HELPED ME FIND A GOOD MAN AND AN EXCELLENT PSYCHIATRIST IN (B)(6), DR. (B)(6). THE VAGUS NERVE STIMULATOR GRADUALLY MADE A DIFFERENCE IN MY LIFE; MY HEALTH WAS SLOWLY IMPROVING. I STARTED NOTICING COLORS IN THE WORLD; I BECAME ABLE ONCE AGAIN TO HAVE A CONVERSATION, TO ANSWER A QUESTION, TO SPELL WORDS, AND TO REMEMBER A TELEPHONE NUMBER BETWEEN READING IT AND DIALING IT. I WAS SHOCKED, AND SO HAPPY. DR. (B)(6) HAS IMPROVED MY RESULTS EVEN FURTHER BY DESIGNING A PROGRAM OF MEDICATIONS. I STILL SEE HIM ABOUT ONCE A MONTH. ALSO, DR. (B)(6) AT (B)(6) MONITORS MY VNS DEVICE WITH QUARTERLY VISITS. WHAT CAN I SAY? THE VAGUS NERVE STIMULATOR SAVED MY LIFE! I FELT SO GRATEFUL THAT I WANTED OTHERS TO KNOW ABOUT THE OPPORTUNITY THEY MIGHT HAVE. I WORKED TO HELP OTHERS LEARN ABOUT THE VNS SYSTEM AND HOW MUCH IT HAD HELPED ME. I GAVE LONG TALKS ABOUT MY EXPERIENCE TO HUGE ROOMS FULL OF PSYCHIATRISTS. ALTHOUGH A SHY, QUIET PERSON, I ALSO DID SEVERAL TELEVISION APPEARANCES, WITH DR. (B)(6) AND THEN WITH THE DIRECTOR OF HEALTH PROGRAMS, A PROMINENT LOCAL TV REPORTER. TO MY DELIGHT, SOMEONE ELSE IN THE AREA WITH SEVERE DEPRESSION SAW THE PROGRAM ABOUT THE SUCCESS OF THE VAGUS NERVE STIMULATOR. SHE CALLED THE TELEVISION STATION, ASKED FOR MY PHONE NUMBER, AND CALLED ME ONE DAY TO TALK ABOUT THE VNS PROGRAM, AND SHE ENDED UP HAVING THE DEVICE IMPLANTED IN HER CHEST. VNS HAS MADE A HUGE DIFFERENCE IN HER LIFE, TOO. THIS EXPERIENCE WAS A TRIUMPH FOR HER -- AND FOR ME. WE BECAME, AND STILL ARE, GOOD FRIENDS. IN 2010 OR 2011, AT ONE OF MY VISITS WITH DR. (B)(6), HIS COMPUTER DISCOVERED "HIGH IMPEDANCE' WITHIN MY DEVICE. WE TOOK X-RAYS, SENT THEM TO CYBERONICS FOR REVIEW, AND LATER LEARNED THAT THERE WAS A PROBLEM WITH THE LEAD; THE DEVICE WOULD HAVE TO BE REPAIRED. MOREOVER, AFTER MEETING WITH THE NEUROSURGEON AT (B)(6), (B)(6), M.D., I LEARNED THAT HE WOULD NEED TO REPLACE THE ENTIRE VNS SYSTEM. DURING A HOSPITAL STAY IN (B)(6) 2011, THE DEVICE WAS TURNED OFF. DR. (B)(6) AND A NEURO-PSYCHIATRIST, DR. (B)(6), HAVE BOTH STRONGLY ADVISED ME OF THE NEED FOR THIS SURGERY. THEY STRESS THAT, WITHOUT THE DEVICE, THEY ARE AFRAID THAT I WOULD GRADUALLY REVERT TO MY ORIGINAL DEPRESSED STATE. THEY ALSO STRESSED THE IMPORTANT NEED TO REDUCE OR STOP SOME OF MY NUMEROUS MEDICATIONS. A DELAY IN THE SURGERY WAS NECESSARY, BECAUSE OF A PERIOD OF CHRONIC BRONCHITIS. I HAD LOST WEIGHT AND HAD BEEN VERY ILL. I NEEDED TO SEE NUMEROUS DOCTORS TO CHECK OUT VARIOUS SPECIALTY AREAS IN ORDER TO FIND THE CAUSE OF CHRONIC BRONCHITIS, TREAT IT, AND TAKE TIME FOR RECOVERY. WE'VE COMPLETED THAT INQUIRY, AND I AM IN MUCH BETTER HEALTH NOW. HOWEVER, SIGNS OF DEPRESSION ARE GRADUALLY RETURNING. I'VE ONCE AGAIN PLACED MY TRUST IN DRS. (B)(6), AGREEING TO GO AHEAD WITH THE SURGICAL REPLACEMENT THEY DESIRED FOR ME. IT HAS BEEN SCHEDULED FOR (B)(6) 2012. THIS IS MY STORY UP TO THIS POINT IN TIME. NOW, AS YOU KNOW, DR. (B)(6) DISCOVERED THE IMPEDANCE. THEREFORE, MY DEVICE WAS TURNED OFF OVER A YEAR AGO AND HAD NOT BEEN WORKING FOR SOME TIME BEFORE THAT. ACCORDING TO THE DOCTORS MENTIONED ABOVE, THE DEVICE NEEDS TO BE REMOVED AND REPLACED. RECENTLY I DISCOVERED THAT THE REPLACEMENT SURGERY WILL COST (B)(6) AND THE COST WOULD BE MY RESPONSIBILITY. I DO NOT UNDERSTAND WHY CYBERONICS REQUIRES ME TO PAY FOR THIS MALFUNCTION OF THEIR DEVICE. I BELIEVE THAT CYBERONICS SHOULD COVER THE COST OF REPLACING THEIR VNS DEVICE. THERE ARE SEVERAL REASONS FOR THIS PREMISE. FIRST, ACCORDING TO THE "INFORMED CONSENT" (SIGNED BEFORE SURGERY AND AGAIN IN 2001), ONE WOULD THINK THAT CYBERONICS WOULD COVER ANY COSTS ASSOCIATED WITH INJURY FROM OR MALFUNCTION OF THE DEVICE. SECONDLY, DURING AN APPOINTMENT TO CHECK THE STIMULATOR WITH DR. (B)(6), ONE OF YOUR CYBERONICS REPRESENTATIVES, (B)(6), WHO WORKS AT (B)(6) WITH DR. (B)(6) AND WITH THE SURGICAL IMPLANTATIONS OF THE DEVICE, TOLD ME THAT THE ABOVE WAS TRUE, THAT CYBERONICS WOULD COVER ANY NECESSARY CARE HAVING TO DO WITH THE VNS DEVICE. SHE TOLD ME DIRECTLY THAT CYBERONICS WAS SO GRATEFUL TO THEIR VOLUNTEERS THAT THEY WOULD TAKE CARE OF ANY PROBLEMS WITH MY DEVICE, IN HER WORDS "FOREVER." SHE TOLD ME I WOULD "NEVER HAVE TO WORRY ABOUT ANYTHING" HAVING TO DO WITH THE VNS DEVICE. THIRD, AT THE TIME OF MY AGREEMENT TO THE STUDY, I WAS NEVER ADVISED OF THE POSSIBILITY THAT THE DEVICE COULD MALFUNCTION; MOREOVER, I WAS NEVER INFORMED THAT ANY PROBLEMS WITH THE DEVICE WOULD HAVE TO BE SOLVED AT MY OWN EXPENSE. FOURTH, I KNOW THAT I HAVE DONE A GREAT AND COURAGEOUS SERVICE TO CYBERONICS BY VOLUNTEERING MYSELF FOR THEIR STUDY OF THE SURGICAL IMPLANTATION OF A NON-APPROVED MEDICAL DEVICE INTO MY BODY. AS ONE OF MANY PT VOLUNTEERS, I HELPED CYBERONICS GET FDA APPROVAL FOR THE VAGUS NERVE STIMULATOR. FIFTH, HAVING BEEN GRATEFUL TO CYBERONICS FOR THE OPPORTUNITY TO TRY A NEW TREATMENT, AND HAVING THE DESIRE TO PLAY A SMALL PART IN OFFERING IMPORTANT NEW KNOWLEDGE TO THE PSYCHIATRIC MEDICAL COMMUNITY AND TO THOSE PTS SUFFERING FROM SEVERE DEPRESSION, I ALSO GAVE MUCH THOUGHT, TIME, ENERGY, AND SUPPORT TO CYBERONICS BY WRITING PAPERS TO PLAN AND PRESENT TALKS ABOUT MY EXPERIENCE WITH THE VNS DEVICE TO ROOMS FULL OF DOCTORS AT CONFERENCES. IN ADDITION, I APPEARED ON A LOCAL TELEVISION SHOW HERE IN (B)(6) IN SUPPORT OF THE VNS THERAPY PROGRAM. I WAS THAT GRATEFUL TO CYBERONICS, AND I THOUGHT (AND WAS TOLD AT ONE POINT) THAT CYBERONICS APPRECIATED WHAT I HAD DONE FOR THEM. SIXTH, THE CYBERONICS COMPANY HAS PLACED THEIR SYSTEM INTO MY BODY TO TRY IT OUT, AND NOW THEIR SYSTEM HAS FAILED. THIS PROBLEM IS NOT A MATTER OF CHANGING THE BATTERY; INSTEAD, THERE IS A PROBLEM WITH THE LEAD, A MALFUNCTION OF THE DEVICE, AND, ACCORDING TO DR. (B)(6), I MUST HAVE THE ENTIRE SYSTEM REPLACED, AT AN EVEN GREATER RISK TO MYSELF THAN THE FIRST IMPLANTATION AND AT MY OWN EXPENSE. I FEEL THIS IS GROSSLY UNFAIR. AS YOU KNOW, (B)(6) INSURANCE COMPANY DENIED A PRE-APPROVAL REQUEST FROM MY SURGEON. HOWEVER, IT WOULD SEEM TO ME THAT CYBERONICS SHOULD BE ENTIRELY RESPONSIBLE FOR THE FAILURE OF THEIR OWN PRODUCT, WHICH HAS BROKEN INSIDE MY BODY AND WHICH COULD BE DAMAGING. IT WOULD SEEM TO ME ALSO THAT CYBERONICS WOULD APPRECIATE WHAT THEIR STUDY PARTICIPANTS DID FOR THEM. IT IS HARD TO BELIEVE THAT THEY ARE UNWILLING TO TAKE CARE OF THEIR OWN STUDY PARTICIPANTS. PLEASE RECONSIDER YOUR OFFER TO DONATE A NEW DEVICE ONLY. THAT, OF COURSE WOULD BE GREATLY APPRECIATED. HOWEVER, MANY MORE EXPENSES WILL BE INCURRED IN THIS SURGERY. I NEED THIS DEVICE. BUT, I CANNOT PAY FOR IT; INSURANCE WILL NOT PAY FOR IT, AND CYBERONICS IS UNWILLING TO PAY FOR IT. I DO NOT UNDERSTAND THIS. THE PT IS TOTALLY CAUGHT IN THE MIDDLE OF THINGS. I DO WONDER IF THERE IS NOT SOME DISCRIMINATION GOING ON HERE, BY (B)(6) AND/OR CYBERONICS. I THINK THAT CYBERONICS SHOULD TAKE CARE OF ALL THE EXPENSES FOR THIS SURGERY, WHICH IS NECESSARY BECAUSE OF THE FAILURE OF THEIR DEVICE IMPLANTED IN MY BODY IN THE YEAR 2000, AND BECAUSE OF MY VERY SEVERE AND CONTINUING DEPRESSION.