Medtronics Defibrillator Lead Recall: Where Was the FDA?
The Medtronics defibrillator lead failures have again raised the issue of whether the FDA’s testing procedures are sound. A congressional oversight committee will review the FDA’s testing procedures for the Medtronics recalled wire component of its defibrillator, which has been linked to at least five patient deaths.
In an letter to FDA Commissioner Andrew von Eschenbach, Henry Waxman (D-CA) requested a thorough timeline of the recall and an overview of how FDA approves so-called "supplemental" parts of medical devices. "Please describe the process by which FDA approves all defibrillator leads," Congressman Waxman's letter states. "Specifically, please explain whether FDA would approve a defibrillator lead under a distinct (pre-market approval) or as a supplement to a PMA for another device." Waxman also cited reports that the FDA did not require Medtronic to submit clinical trial data on these recalled leads and requested an explanation for the FDA's failure to do so.
Certainly, the FDA needs to do its part in analyzing the safety efficacy data on these products. But it the end, the burden lies with Medtronics to do all that it can to make a safe product. The race to get these products on the market is furious. Medtronics and other medical device companies selling defibrillators rush out new defibrillators that may be technologically superior, but with no proven history of safety and reliability, because they want more market share. The FDA does not have time, energy, manpower, whatever, to properly evaluate the safety of the product. Yet at trial, you can bet that Medtronics defibrillator recall lawyers that are representing the victims will hear one defense theme over and over: “FDA approved.” The solution to this problem would be to exclude evidence of the FDA approval; it is of limited probative value to demonstrate safety of the product, and it is likely to mislead the jury, because they may incorrectly assume the FDA approval process is more vigorous than it really is. I think this is a reasonable solution to this unfair hurdle that plaintiffs’ pharmaceutical lawyers must face in every case.
Comments
TODAY I HAVE AN APPOINTMENT TO GIVE MY PAIN MANAGEMENT PHYSICIAN AN ANSWER TO HAVE THIS UNIT PUT INTO MY BODY. IS THIS SAFE? WHY ARE THEY STILL PUTTING THESE MEDTRONIC DEVICES IN PEOPLE? MRS. CHAMBERLIN
Posted by: LORENA | February 16, 2008 3:52 PM
Dear Lorena,
Don't do it. My husband had one and got a bad lead. The insurance won't pay to take it out, Medtronics has been absolved of all responsibility by the US Supreme Court because the FDA approved it, the FDA is sovereign so we can't sue them, and the physicians were all lied to.
If we had it to do over again we would not do it.
By the way, Medtronics gave us magnets to temporarily disable it. They are so huge we store them in the garage. They are heavy and big and you can't walk around with them.
Just don't do it and pray for my husband.
Betsy Smith
Posted by: Betsy L. Smith | February 22, 2008 7:46 PM
I had a Medtronic's Defibrillator lead on June 13th 2006. A out patient procedure I was told they would implant it and I can go home the same day. To make a long story short the Lead they put in fell apart and I was in and out of the hospital all summer.
Then the Lead I have inside me has been recalled. The other defibrillator punch a hole in my heart and lung.
Since then I have had a lot of unexplained pain that the Doctor can not or will not find. My Cardiologist has referred my back to my regular Doctor.
This thing has ruined my life. I have not been able to walk up stairs because of shortness of breath etc and so on.
I too would like to know, Who is minding the FDA when medical devices and prescription drugs are put out on the market that do bodily harm and injury to the people they are supposed to help..
The last visit my heart doctor said that I could take the pacemaker and defib. out. And live with congestive heart failure. I can't and don't want another surgery and I don't know what to do. I am 47 years old and I do not want to live the rest of my life in pain or in fear of instant death
Posted by: Brian Coit | May 18, 2008 3:27 AM
My dear husband of 40 1/2 years had a Medtronic defibrilator put in on February 11, 2008. He died on June 1, 2008. His defibriltor shocked him 3 times while I held in in my arms. From the first shock, I knew he was gone, all he had was a blank blue-eyed stare. They are saying his heart quit because it was so weak and couldn't be restarted. I am wondering if they had his defibrilator programmed too low. I am still stunned on losing him so early in life. He turned 60 in December of 2007. He had so much faith in this defibrilator, it hurts me knowing it was useless when he needed it the most.
Posted by: Donna Chivari | June 19, 2008 11:38 PM
i was sleeping when my wires fractured and gave me a shock that woke me up i thought that i was dying and i went to the hospital by way of ambulance and they replaced my pacemaker and just laid wires down beside my defective wires and my doctor said that these wires could blow within 6 months all this problems and it goes on and on
Posted by: ricky simpson | July 24, 2009 12:48 AM
regular doctor visit reveal that my wires to defibrillator had been loose for 6 months this problem cause me to loose a lot of blood that almost killed me.iam stile having some pain and unnecessary shock.everyday i lived with the fear this might happen again
Posted by: mary parrish | July 29, 2009 12:34 PM