People, I AM LIVID!!!!! When the FDA approved the vns they set "Conditions of Approval" on the device. They included a 450-patient dosing study and a 1,000-patient out-come registry. Do you know that to this day those conditions still have not been met? I read the minutes to the meeting the heads of CBYX had in Cyberonics, Inc. F3Q09 [QtrEnd 01/23/09 Earnings Call Transcript and not only do they admit that they have not met the FDA's mandated "Conditions of Approval", but they have not even started them yet! They're chit-chatting about how they are going to ask the FDA if instead of doing a 450-patient dosing study and a 1,000-patient out-come registry, that they lower it to a 320-patient dosing study, and I forget how many for the out-come registry, but I'll find out. But all that is niether here nor there because as far as I am concerned, if Cyberonics after all these years has not only failed to meet the FDA's Conditions of Approval but have not even begun the process to start them, then Reigel vs. Medtronics does not apply to them. Reigel vs. Medtronics applys' to FDA approved devices but if the company has not MET that approval criteria mandated by the FDA; nor have they even begun then Reigel vs. Medtronics does not legally apply to them! I know that I am repeating myself, but I am pretty pissed. They have reduced their debt from $132.5 million [where it stood 5 quarters ago] to $62.3 million. Well that's real great because now that my 45 year old sister is on permanent Social Security Disability because of this device and because I now know that Reigel vs. Medtronics legally does not cover their sorry asses anymore then it's time to LAWYER UP!!!

I think someone is misinformed. Cyberonics started the treatment registry shortly after they got FDA approval. The primary reason there are so few participants in the treatment regestry is because no one can afford a VNS without insurance reimburesment. My recollection from Cyberonics Wall Street press releases is that they anticipated "selling" only about 100 VNS a year worldwide to people with depression unless insurance reimbursement becomes available.

Cyberonics may have been required to do a 450 person dosing study, but back around October they concluded they only needed about 330 patients to generate the statistically significant results being sought and petitioned to have the number of patients in the dosing study reduced. If their petition is granted (and for all I know it may already have been granted), then they can reduce the number of patients in the dosing study to 330. If the petition is denied then my understanding is that Cyberonics will have to start recruiting more test subjects to bring the number in the dosing study to over 450.

Either way I think Cyberonics is in at least technical compliance with their agreement with the FDA. If the petion to reduce the number of study participants is approved, they are in compliance with the FDA's revise requirements; and if denied they will have to increase the size of their dosing study to meet the their agreement with the FDA. Because the dosing study is ongoing I don't think Cyberonics can fairly be accused of violating their agreement with the FDA< at least not yet.

[edited:posting personal information is against forum rules]

KURT VAN KAMPEN

:Welcome: Kurt
Thank you I believe you are correct in your assessment. It's just very confusing and quite complicated.

:D HI Kurt and on behalf of all of us here, I would like to :Welcome: you to the VNS Message Board! Glad you found us, and hope to get to know ya!

I believe your assessment of the situation is correct as well, although I do also think it is very confusing and complicated.

A lot of people were let down when Cyberonics decided to petition the FDA to lower the # of study participants. People already had surgery scheduled, and then got cancelled pending the FDA's decision.

I don't recall reading if a decision has been made yet on the petition.

Take care!
B)

Mr. Van Kampen, I am not trying to knit-pick here, but I believe YOU are wrong. The original "Conditions of Approval" were a 450 patient post-marketing dosing study and a 1,000 patient out-come registry. in Cyberonics' QuarterEnd 01/23/09 Earningscall Transcript Anthony Petrone asked Daniel J. Moore for an up-date on his request to the FDA to change the structure of the TRD post approval study. Mr. Moore explains that a request was submitted to the FDA to change the enrollment from 460 patients to roughly 330; to which Gregory H. Browne guestamated that over a 12-month period would be a savings of $3 to $3.5 million. He then stated that it would be signifigant enough to wait to see what the FDA says. Once again, this transcript call took place on January 23, of this year. Unless something radical, such as a very localized time warp happened, then I cannot possibly see how they could have completed this task. It almost makes me wonder, did they orriginally start off with "roughly" 330 people? Or did they have the required 460 that were mandated by the FDA? If they did have the required 460, what happened to them? Oh yeah. That time warp thing again. By the way, Mr. Van Kampen, you wouldn't happen to be with Van Kampen Investments, you know, the stock people? Cause if you are, you already know all this. Chip Burgess from Van Kampen Investments was there. I guess everyone likes to do a little fishing now and then, right? NancyB

I wish I was affiliated with Van Kampen investments. Instead, I am just a poor disable depressive.

I think I have some information on what happened to the "missisg" 120 vns test subjects. I don't think Cyberonics had finished recruiting the entire 450 when they suddenly told all their test sites to stop further recruiting and to also stop doing implants on already approved patients whose surgery was imminent.

KURT VAN KAMPEN

:D HI Kurt!

Have you heard if the FDA granted approval of CYBX's petition to decrease the # of study participants?

Take care!
B)

WARNING LETTER: U.S. Food & Drug Administration Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145 December 22, 2004 REF. 205-DAL-WL-7 Warning Letter, Certified Mail, addressed to Mr. Robert[Skip] Cummins, President & CEO Cyberonics, INC 100 Cyberonics Blvd. Houston, Texas 77058-2017 During inspection 7/12-19, 2004, FDA inspector Ellen J. Tove determined VNS, manufactured for seizures for patients 12 & over with medically intractable partial seizures. Products defined in Section 501 [h] of the Act...are not in compliance with the current Good Manufacturing Practice [GMP] requirement of the Quality System [QS] Regulation for medical devices, as specified in Title 21, Code of Federal Regulation [CFR] Part 820 Form FDA-483 identified QS regulations: 1] Failure to completely investigate and eveluate each medical adverse event required by 21 CFR 803.50[h][2] and failure to maintain complete deliberation results as required by 21 CFR 803.18[b][1][i][FDA-483,Item 1] For example, your firm has not provided adequate documentation...for explaining why your firm could not reach a conclusion about the cause of [a] device migration reported in complaint file #200312-0567 [reference MDR report #2004-00030]. [go down the page a little] b] Your firm has documented DEATH DATA by age catagories to support data analysis required in CAPA investigation Report INV01-0006, dated January 8, 2002, and Febuary 19, 2003 28 patients of 81 UNKNOWN. Your firm also had not collected programming history data assess the relationship of the amount of stimulation therapy AT THE TIME OF DEATH...The firm did not document or evaluate reasons for broken leads; high lead impedance...Review of complaint data queried by conclusion code 40 showed that your firm had classified 1081 complaints & 524 MDR Reports using this code;....from Jan. 1, 2002- May 14, 2004: 197 serious injury reports, 53 DEATH REPORTS, 99 malfunction reports code 212 [unapproved use of a device] Sincerely, Michael A. Chappell Dallas District Director http://www.fda.gov/foi/warning letters/g5129d.htm Anybody who wants to read the entire letter can see it for themselves Then you can look up the minutes to the UNITED STATES of AMERICA FOOD & DRUG ADMINISTRATION Neurogical Devices Panel of the Medical Devices Advisory Committee Seventeenth meeting June 15, 2004 Panel met 8am at the Holiday Inn, Gaithersburg Walker/Whetstone Rooms, Two Montgomery Village Avenue, Gaithersburg, Maryland, Dr. Kyra J. Becker, Chairperson, presiding Drs. Kyra J Becker and Laura Frochtmann- waivers were granted for their interests in the firm Data showed adverse event perculiar or specific to depression was the rate of emerging MANIA or HYPOMANIA, especially in bi-polar patients. Following FDA approval for epilepsy in 1997 the sponsor conducted a 30-patient, later expanded to 60-patient pilot study called D01, then D02 in 2002, the study failed, wanted to do D04, FDA voiced concerns. The most COMMON adverse event: DEPRESSION. In D01-12 suicide attempts, D02: 1 suicide, one sudden death: Long term D02: 7 suicide attempts in 6 patients, 2 more in 2 patients, D03:2 suicides, D06: 1 suicide, 2 attempts in 7 patients. Anyone can look up on their computers and get the minutes, which is word for word, to any FDA advisory committee meeting and read all this for themselves. They can also look up the ORIGINAL Conditions of approval and the reasons given as to why they were NOT fullfilled. They can also pull up all the warning letters. Nancy B

Where have you been Kurt? Visit us again.

:wacko: I have been on the internet searching for answers and all the while we are going from one doctor to another trying to get help for my hubby, Nancy B
you seem to have the intelligence and the know how I don't. My hubby
was a sour puss and a quitter all of his child hood, (parents insisted he was)
but what a guy he became, one problem he had was depression, bad depression,
so when his dr. was at the end of his different med coctails for him, he came up
with this implant to make everything better..(by the way, this period of depression went over the 25 years we have been married and he was ill before that).. We live in a very small town, so we traveled to Savannah Ga to get this implant (the VNS)... OHHH.. and the doctor also told him he might be able to be without drugs with this implant, or atleast cut way back on the meds.
NO....NO....NO.... very little change went on.....almost from the beginning everytime it would come on it would burn from the generator all the way
to the vagus nerve, and still shocks him untill 3 weeks ago and we insisted
the doctor turn it off.....at that point my hubby had not slept in 3 weeks,
well he give him the trazadone-thorazine coctail, still no sleep....so he stopped
all of his meds and started him on some new ones, still no sleep, ohh I forgot also
his heart rate was at 131 to 162 per minute.. He did not have the energy to lift his
head, I was watching my husband die, and no body was saying or doing anything.
We kept going to the emergency room, still no help, much more blood work was being done, mri and scats being done, finaly we had one doctor that has found
a problem with his adrenal gland and something wrong with his liver....could it be an over dose of meds???
Well, with the machine off.. his heart rated is back normal.... and there is no more
burning in the chest to the throat.... but he is still with headaches, upset stomach,
bad fatigue, and his muscles are wasting away.... HE IS SICK..
If anyone can help or make any suggestions we are listening...

Welcome mama myers :Welcome:

The symptoms you described are all listed in the adverse events. Your husband has had a bad experience with VNS. One of the biggest obstacles patients have is getting the doctor to even consider the VNS may be the root of any new problems. I believe many of these medical professional have no clue as to the scope of problems this device can and does cause.

I'm so sorry the VNS did not help your husband and in fact made his situation much more intolerable. Insisting it to be shut off was the best thing you could have done. Over time many of his symptoms will go away or at least lessen.

I suggest you have your husband visit an internist, have a nerve conduction test on the vagus nerve to see if it has been damaged and as to what extent.

Thank you, let me up date you on what has evolved in the last 24 hours, as of yesterday some blood work has come back from the internist, his blood work showed somehting is going on with adrenal gland, stress related from all of this, probably, but we are in route to an adrenaologist, I can't spell, we were at a neurologist yesterday, where he did the hammer on the arms and knees and
said no way is his vagal nerver damaged, he would not be here.... he could not
even get his probe from cybernomics to work, and then put it on the floor and
rolled his chair across it and said he was one of the first on board doctors with
cyernomics....I think we have a bunch of loosers for doctors around here...
except for our internist, who is trying but not getting any where with
these looser doctors...we need to get a list of neurogist that is within driving
distant so my hubby can get some help....we are limited in SE Georgia

:D HI moma myers and on behalf of everyone, :Welcome: to the VNS Message Board!

I agree with what Birdbomb said. Please be diligent about your husbands care. I am sorry to hear yet another tragic story involving VNS.

I don't agree with what the doc said to your husband and you that he does not have vagal nerve damage or he'd not be here. I say this because I have vagal nerve damage and I am still here. My device and coils have been removed, yet I still have a consistently high heart rate & high blood pressure issues, and those were not issues prior to VNS, but became issues after stimulation began, and remain to follow me. Please consider a second opinion although I understand docs are limited in your area.

Please do keep us updated. I am glad you joined us, and am looking forward to hearing from you again soon!

Take care!
B)

please tell me how did you go about finding a qualified doctor, and do you think we
will ever make it to see that this company does no more damage to other healthy people....thank you for the warm welcome.... :blink:

:D Hi moma myers! You are more than welcome!!

Go thru your insurance provider handbook to find a doc and start calling. It will most likely take a gazillion calls and your frustration will peak. I am sorry you have to go thru this.

As far as Cyberonics being held liable, they have some lawsuits pending against them for a variety of things. Due to the Supreme Court decision regarding Reigel VS. Medtronics, device manufacturers can get away with a lot.

Take care!
B)

we are on social security, limited income, and limited providers as medicare does not help you to obtain a doctor....NO we are not old, just my sweet hubby has been battling TRD for about 30 years, he is now 54, and I have been ill myself.
I have been on the internet for days trying to find a dr... still no answers...

Thanks for your input anyway...just thought it would be a shot in the dark...
:Really Mad:

Hi mama myers! Welcome to the Message Board!

I'm sorry you're in this position; both of you not feeling well and needing to move forward with care for your husband when it's difficult to find the right doctor.

I hope you can temporarily put your anger and frustration with Cyberonics on hold and focus your energy on taking care of your husband. You know that approaching a new doc with grievances with past doctors does not give you a very good start. If at all possible, work with this internist and assure him that all you want is to get the best care possible to remedy your husband's medical problems.

I always mention that you should document EVERYTHING...I keep a notebook and write down the date, the doctor (or name of the person I am speaking with) and put down a summary of the phone conversation or what went on during an appointment.

We've all had (or have) desires to see that Cyberonics be made responsible for the many problems they've caused...but there have also been people (I'm one) who have also had huge benefits from my VNS.

So many of these situations with companies like Cyberonics takes years to make right....as I already said...use your energy now to care for yourselves!

Oreo

:D Thank you Oreo, I am doing just that, and I guess I am using VNS board as a sound off, because I can't just start screaming.....you are right, there is some people that have benefited from the vns, unfortunately there is some people that have also digressed....being said, the vns is alot like people, some of them are good and some of them are bad.

I know there is a very good chance that we might not be able to make Cyberonics to accept responsibillity for anything, but maybe we can stop another company from doing the same thing. On November 20, 2009, the Neurological Devices Advisory Committee, I believe between the hours of 8-5, to vote on the pre-market approval on yet another device, similar to the vns, the "Kinetra", which is manufactured by Medtronic, for the treatment of partial on-set epilepsy. This information can be found at http://www.medscape.com/viewarticle/573989_3 and http://wwwp.medtronic.com/Newsroom/NewsRel...=pdf&long=en.US. This is another neurostimulator device. The contact person is Deborah Falls, Center For Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Silver Springs, MD 20993, 301-296-6459. The Advisory Committee Hotline is 1-800-741-8138. I don't know how much influence we could have, but for my sisters' sake, I have to try. If they are going to let these companies produce these devices, we should at least be able to be compensated when they harm us. There really needs to be some drastic changes in the laws.

Nancy, IMHO I believe the biggest problem with VNS is the location of the initial stimulation. The Vagus nerve. That nerve is vital for the entire body. The neurostimulator that Medtronics devised, by-passes the vagus nerve altogether and has electrodes located on the seizure focus. This eliminates MANY of the adverse events.