edited in by Chemar Please go here to read the statement http://www.parkinson.org/getdoc/59a6...36f411/default

http://www.startribune.com/business/...1.html?refer=y
Star Tribune

A deep brain stimulation device used to treat conditions like Parkinson’s disease was classified Thursday by the U.S. Food and Drug Administration as a Class I recall — meaning the FDA believes there is a “reasonable probability” that a device will cause “serious adverse health consequences or death.”

But on Friday, Medtronic and two doctors said that patients are not in imminent danger. “No one’s going to die,”said Dr. Bryan Klassen, a Mayo Clinic neurologist who specializes in movement disorders and Parkinson’s.
Said Dr. Ali Rezai, a neurosurgeon and director of neuromodulation at Ohio State University: “It’s definitely not life-threatening. That is really incorrect. … I was very surprised by this.”

FDA officials on Friday did not respond to a request for an explanation about the recall classification.
Ihle said Medtronic has proposed a manufacturing change to fix the problem. That is under FDA review…

No one, Ihle said, has been reported to be harmed as a result of the problem.

Why, then, did the FDA *classify this as a Class I recall? “We certainly can’t speak on behalf of the FDA, or their reasoning behind the classification,” he said.

QUOTE: National Parkinson's Foundation Statement on Recall of Medtronic DBS Component
Release date: May 6, 2013

..."The manufacturer of deep brain stimulation (DBS) devices used in the USA and internationally, Medtronic, Inc., of Minneapolis, Minnesota, announced on May 2nd a risk of damage to DBS devices associated with the use of a component used in DBS surgery. The FDA classified this as a Class I Recall indicating high risk to patients. Medtronic had notified physicians of this issue in February." QUOTE...

"High risk to patients" is a watered-down definition of what the FDA said.
Class One is the most severe recall warning in the FDA's arsenal.

This is what the FDA means by Class 1:
..."A deep brain stimulation device used to treat conditions like Parkinson’s disease was classified Thursday by the U.S. Food and Drug Administration as a Class I recall — meaning the FDA believes there is a “reasonable probability” that a device will cause “serious adverse health consequences or death.”

How y'all like that with your breakfast coffee?

That FDA evaluation is still the official FDA evaluation.

Today is May 7. Medtronic sent out the letter to doctors - and to the FDA, - in February. What happened in those three months, from February to May?

The very first mention of the "recall" (has anyone been called?) was on this forum, on May 3, posted by Lindy Lanka, a patient.

Not the doctors, not Medtronic, not the FDA, and not the Parkinson's organizations. The first information made public and addressed to Parkies was from a patient. Three months after the doctors and the FDA were notified by the manufacturer.

What went on during those three months? Obviously nothing involving PwP awareness during their Awareness Month.

How did this go on for 3 months in secret and then out-of-the-blue the FDA tells us about the "reasonable probabilty" that something might happen, such as "death" and so there is a recall... but no one is being called.

Just ask Alice when she is two feet tall.

Hi Bob, would like to say that the first time I heard of this issue was from this forums' Violet Green, on the day I posted it. I believe that she read about it through a listserve. Perhaps she will be able to clarify which one. So I was more the messenger than the origin of this information. It was the result of a chain of PwP connections.......

As often, it is through the Pwp/patient network that such issues rise to the surface; without it most of us would be singularly ill-informed on just about everything we need to know, about managing and living with PD.

The fact that this arrived via the financial news media and not the medical/healthcare route just highlights our place in the scheme of things. For us the 'tiny' amount of people who could be affected are not negligible. They ARE us, regardless of whether we have had DBS or not. For all of us with PD, our disease could have gone wherever it needed to warrant the decision, never taken lightly, to have DBS surgery. In this respect as a person who is unlikely to ever be the recipient of such surgery, I still stand in solidarity with those who have done. In this case, even if the eventual numbers are found to be few, I believe that there is a right to be informed and that Medtronics' obligation should be greater to patients than to shareholders.

Lindylanka

https://www.michaeljfox.org/foundati...lation-surgery

“Medtronic tells The Michael J. Fox Foundation (MJFF) that the reported adverse event occurs at a rate of 0.25 percent when a lead cap is used during surgery.”
Medtronic is thereby telling the MJF Foundation substantially less than they told the doctors and stock analysts in their letter of Feb. 2013. Here is the same sentence 3 months ago:
“… has been reported with 0.25% of the DBS leads distributed, however, this incidence is lower than the expected actual rate of occurrence since every event is not likely to have been reported and the actual number of uses of lead caps is unknown.”

So the number is higher than a quarter of one percent, but they don’t know how much. They’ve done 114,000 of these, so how many patients are getting hit? 300? 1,000? Not many, everybody is saying.
But we OWE these people. Medtronic is now marketing the device around the world, for more diseases than just PD. But it was PwP who were the guinea pigs for this process.

ALL surgery is a risk?
Agreed.
The number of patients suffering a hardware and software upgrade will not be enormous.
Agreed.
It is a technology that probably will do things in the future that we can scarcely imagine today.
Agreed.
The FDA has jumped the shark.
Agreed.
This issue is being well-handled by the Parkinson’s Empire.
Disagree.
Just simple things, like sending one letter to the medical industry in February and then a truncated version 3 months later, to patient advocates, feeding them pabulum.
Just the whole sequence of events.
It is a desolate charade. For shame.
For shame.

I am so thankful for your kind help.

My disability made me very self-conscious and quite depressed at times. I had got to the stage where I was finding it too difficult to even write and this is my first letter in ten years.

I feel that you and the professor and the doctor have given me a new lease of life.

I watched my father, who I inherited the disease from, go through his life progressively getting worse, incapable of doing the simplest of daily chores like eating and drinking without aid and could only see myself going the same way.

I am only 52 years old but I had been noticing my shakes getting worse, so for me to have my operation regardless of what it involved has been a real life saver and no words can express my absolute gratitude.
Thank you
Rita Carlisle

Hey, doc! You just saved another life.

Gooooood-mooorning Medtronic!!!
(soundtrack: Ride of the Valkyries, helicopters approaching at tree height)

Deep Brain Stimulation is one of the truly great accomplishments in the history of medical science. And PwP were substantially involved, as volunteers, for clinical trials, and as the first patients to dare to have it done to them.

People with Parkinson’s were there when it happened. They helped make it happen. They should be proud of themselves, and you should be proud of them. They should be treated with the utmost respect by the industry that grew up around their illness.

This absurd and surreal FDA “Class 1 recall”, fumbled from start to finish, is a perfect opportunity for Medtronic to defend its people, and its product.
And “its people”? Yes, the scientists and doctors… and the patients.

A small number of people, we are told, have been affected by caps designed to protect the lead inserted in their brains.

It was the luck, or bad luck, of the draw; it could have been any of us; many do not even know if their treatment involved use of the cap or not.

It is obscene the way these patients have been left dangling by this mini-farce operetta being played by the FDA. What has happened there should be thoroughly explained, and understood, instead of being belittled, feeding us bromides and pabulum, and forgotten about.

If you ignore the ”recall” and wait for it to be forgotten, it would most certainly tarnish the reputation of your whole futuristic project. Nobody gets away with anything, ever. That's a law of the universe: every grain of sand is numbered.

Track down the patients who suffered damage; guide them through a retro-fit; if needed; at no additional cost to them, and give them a thank-you gift and high praise.

One of the aspects of the Parkinson’s personality: when they get treated like cattle, they participate less. Treat them as equals, and they will emerge from their lonely sentry posts. And that’s not the Mirapex talking.

They are heroes, and should be treated as such. It would be a wise investment for Medtronic to make a grand gesture of justice; to cut the quibbling and the P.R. crap and be utterly transparent about the history of DBS, from its earliest days to now; because it is a glorious history, and it is a technology still in its infancy; a technology with a great future; and PwP are very much part of that history. And now, a small number have to go through the damn operation a second time, because of a minor glitch that no one could have foreseen. MDT, join us in saying, as say the Marines, we will not retreat from the battlefield and leave our wounded people behind.

The history of electronic brain stimulation has only just begun; don’t mess it up now, because history is hard to take back once it is done.

PwP offered up their living bodies and their living minds to make this history happen. One by one, the patients said, “Doc, let’s do it.”

Now, Medtronic, DO THE RIGHT THING. And then some.

And as for the FDA, it may take more time, as they seem to have morphed into some sort of doomsday cult of refuseniks. Their Import Refusal of Duodopa; their “Class 1 Recall” of DBS ; the only two alternatives PwP were examining, are stuck at the FDA.

Has the FDA started testing all the drugs on themselves? Has testing agonists made them irrational and dangerously compulsive – obsessive? After spending too long in the suntan machine?

I knew a guy like that. Then one day his urine sample exploded.

Some people just don’t know when to quit. Or what to quit. Or why.

But this case is very simple.

Fifty thousand years ago, we painted on the walls of the cave.
Twelve thousand years ago, we invented agriculture.
Ten years ago, we started wiring up our brains.

Those who accomplished this unimaginable medical revolution; those on both sides of the scalpel, are heroes.

A small number of the heroes were hurt by a small piece of plastic. That can be fixed. In a victory parade, not a funeral march.

Don’t show the FDA how fast you can bully your way past a “Class One Urgent Recall”. Instead, demonstrate to the FDA how a Class One medical team treats their Class One patients: be a Class Act.

Be transparent and be generous and be true, and you will, over time, notice that you are getting more volunteers, and more support, than the Pharma firms who simply hand every question over to their lawyers, to lay down a thick fog of deception and delay.

Say, by taking action: “We ain’t like them other folks. We take care of our people.” You will find it rewarding, in every way.
Show us your colours, MDT. Make it shine.
Bob Dawson

The FDA Patient Network Blog:
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Bob, I hope you know that I applaude your tenacity. As I understand this recall is because the leads may have been damaged during the surgery. I ask whether a patient may have been given these caps but the leads were not damaged. They have been successfully treated and are having good results. I don't understand how they are going to do anything beyond assist those who may be having problems. If it ain't broke they aren't going to do anything for you.
I think this recall action should be focused on the physicians and to inform them of this and then to replace these caps with something else. Recall the DBS caps. I got the impression it was technique and not necessarily device related.
GO GET 'EM

May I ask? Yes, Caveman Jim, ask away

Bob, I hope you know that I applaud your tenacity.
It’s the Mirapex, Jim.

As I understand
As YOU understand, Jim? Now we are in another dimension. I am the walrus.

this recall is because the leads may have been damaged during the surgery. I ask whether a patient may have been given these caps but the leads were not damaged.
From conversations; statistics not official:

80 % of the surgeons never used the protective caps.
20 % did, but not always.

Usually the cap did no damage and the treatment went as well as expected.

Why are they bringing in a better and safer design of caps from Europe? Why not stop using the caps altogether? I don’t know.

It seems likely that some PwP will require a second operation. It will be MUCH easier than the first, because drilling, implanting brain zapper, etc., are all done. Just gotta replace the wires, which is why I advised them to just bring in a handiman electrician, non-union.

I have heard from one source that 80,000 of these operations have been done; another source says it was 114,000 operations. The company states problems with one-quarter of one percent of the operations; in another document they say that number is too low, because of “events” not being reported, and because they don’t seem to know how many times the surgeons used the caps. That sounds like sloppy record keeping, surely they must have written down what they did in each operation.

They have been successfully treated and are having good results.

Yes, most PwP for whom the caps were used, had good results, as good as no caps. The caps are also used in other countries, with success.

I don't understand how they are going to do anything beyond assist those who may be having problems. If it ain't broke they aren't going to do anything for you.

That is correct. Most people suffered no damage. They will not get a second operation, because they don’t need one.

Any help given will be to those who had the cap used, but who are showing no benefit from the treatment…different levels of intervention will be required. We want MDT to err on the side of generosity to the patient if there are disputes about just how “Off” you get or how much benefit you are getting from the treatment. But I doubt that patients will demand a new operation frivolously. It’s not that much fun.

The craziness of Parkinson’s is a problem. For them, not for us. The FDA assumes everyone fits a category. Some of the Parkies have been horsing around with things like changing the signal strength and changing the frequency of zaps to your brain…

Don’t forget, these are PwP’s. There’s always somebody like Rick using it with starter cables and a truck battery… or somebody like me trying to get the electrical pulses lined up with the Stones singing Street Fightin’ Man.

The FDA panics because this is worse than Cataclysm Code One, at least within their life experience, and they scream: What category are you in?
PWP: The category of who wants to free you from your own prison, baby. Drink some of this. It’s home brew dyn-o-mite. Cure all aches and pains.
FDA: who are these strange people?
PWP: we are the future honey. We use our brains to control our brains. Now zap my brain onto over-drive and let’s get down.
FDA : Am I here all alone? Weren't these people all recalled?

The civil servants at the FDA all believe that Ralph Nader was talking about life itself – not just Chevrolet Corvairs – life itself is unsafe at any speed. When they meet some of these Parkies, and especially the self-created civilian scientists, the cultural dissonance is deafening.

You are the patient, so act sick when the inspector comes around. They are confused when you turn on and off. When they ask you how you are doing, burst into laughter. Practice vomiting on command. Speak in tongues.

I think this recall action should be focused on the physicians

Yes. But MDT should take charge. And I resent that they all brush us aside by saying Go See Your Doctor and leave us out of it. No way. Of course we have to see the doc. But there was a team, remember? Doc is just one of my players.]

I got the impression it was technique and not necessarily device related.
Funny, that’s what women always tell me.