FDA finds problems with Medtronic's M...

FDA finds problems with Medtronic's Mounds View operation

There are 6 comments on the TwinCities.com story from Nov 18, 2009, titled FDA finds problems with Medtronic's Mounds View operation. In it, TwinCities.com reports that:

Medtronic said today it is responding to a warning letter from the Food and Drug Administration about procedures at the Minnesota headquarters of its heart implants division.

Join the discussion below, or Read more at TwinCities.com.

Irish Muse

Minneapolis, MN

#1 Nov 18, 2009
Since thousands of Medtronic's cutting edge heart devices are in patients worldwide, it stands to reason that doctors should be informing Medtronic ASAP when device situations develop. If a troublesome device issue or pattern starts to develop then the company blows the whistle and takes the necessary corrective actions. That's how the system is supposed to and does work.

As a Medtronic device patient I have always been informed of issues regarding my implant whether or not it was necessary. It seems strange that the FDA has taken this action toward Medtronic when the FDA, historically, is the paragon of bureaucratic slowness[putzyness] when it comes to procedural notifications in its oversight programs.

When the medical community cries "Wolf!" in a critical treatment situation regarding life and the heart, everyone from the bottom up should be taking note and trying to solve the issue at hand. As I device recipient, I am trusting the system, besides my own diligence, to keep me abreast of changes or recalls etc. so I can continue living my life fully.

I am a testament to the fact that the notification system works. However, personal diligence, knowledge, and experience should prevail over situational ignorance to keep me alive and enjoying life. This beats waiting on any FDA mandate or edict causing me to panic or be overly concerned on correctable matters.

Minneapolis, MN

#2 Nov 18, 2009
I found out about the Medtronic recall of my insulin pump supplies through the newspapers. Not exactly how I wanted to learn about it, considering the possibility of DEATH existed. Medtronic has improved my life, but I DO question their selection of suppliers/manufacurers and also their diligence in notifying people in a timely manner. Medtronic also bulldozed my favorite driving range to build that "corporate monstrosity" in Moundsview. They have two strikes in my book. LOL!

Chicago, IL

#3 Nov 18, 2009
I am telling u fda is getting tough

Saint Paul, MN

#4 Nov 19, 2009
My son, Robert Wallace Baird (please see robertsfight through Facebook) is testament to exactly what this article is referring to. He died on September 14, 2006, suddenly and unexpectedly, at the age of 16. Not only were we unaware that there were problems with his pacemaker (it was known a year before he died) but his doctors were unaware. Perhaps the system works for many, but my son can't be replaced. We should all have the right to know what is going on with a medical device that has been implanted in our bodies. It is no different than us having the right to all our medical records or everything there is to know about medications we take. My son slipped through the cracks. We had no idea. My son asked me 3 months before he died if he would be ok. Can you imagine how I feel now? NO notifications came our way. Let's make these large corporations accountable and safe. Check out the Medical Device Safety Act ("MDSA") bill trying to get passed in Washington. More people are affected by this than most of you think.
Mark Baird

Saint Paul, MN

#5 Nov 19, 2009
Why is Medtronic being warned again? Is there something they are trying to hide? Are they trying to cover up negligence?
And because of Riegel v. Medtronic not one person is able to bring a suit against medical device manufactures to even discover if Medtronic violated any laws. Nothing. The judges have said, "To bad. My hands are tied because of the Supreme Court." Is my sons life not even worth a day in court? Can anybody bring back my son, anybody?
Some of the most powerful men and woman in the Republican and Democratic parties debated the rights of embryonic stem cells and these very same men and woman will not even give my son his day in court by passing the Medical Device Safety Act of 2009. What would you have me do?" Should I quietly go away like my son did at 5:30 in the morning of September 14th.
And yes, money will not bring my dead son back but that is what the law gives me. I did not make the rules. These are the same rules that every citizen of this state has when they have been injured or killed, accept of course if you were injured or killed by a medical device that is approved by a politically influenced and underfunded FDA. Congress will not give the FDA the funding it needs or the political autonomy from political influence and yet I am not able to bring suit against a medical device manufacturer for the death of my son.
If society can give me back my son, for just five minutes so that I can hug him, smell his hair, hear his voice and feel his warmth I will give up everything. Everything for just five minutes, my own life. What would you do? I only want what society for a brief four years gave to a embryonic stem cells, the opportunity for my sons day in court, a public hearing, a public discussion and debate. Is that to much to ask for? For a sixteen year old boy that put his trust in everyone to do the right thing.
I will not quietly go away as my son did at 5:30 in the morning. He is my son and I am his father.
http://www, robertsfight.com
Mark Baird

Saint Paul, MN

#6 Nov 19, 2009
"That's how the system is supposed to and does work."

It did not work that way for the Sprint Fidelis leads. My dead son was not reported to the FDA due to his faulty medical device that has since had a Class I recall. Was their negligence or fraud involved? Did someone break the law? Is my son the price that I have to pay for innovation? Because of the Reigel v. Medtronic Supreme Court ruling of February 2009 I will not have the chance to discover this. Would you not want that chance just like every citizen of this state does with any other product that injures or kills them?

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