May 2008 Update: Sprint Fidelis Lead Wire Failures Due To Design Flaw, Not Doctors
Medtronic Had Initially Suggested That It Was Implant Technique That Caused The Sprint Fidelis Malfunctions
(Posted by Tom Lamb at DrugInjuryWatch.com)
For today's post we have to thank Westby G. Fisher, MD, FACC, who is a board-certified internist, cardiologist, and cardiac electrophysiologist, as well as an associate professor of medicine, in Evanston, Illinois.
Dr. Fisher is better known to some of us as "Dr. Wes", the name of a blog that he began publishing in November 2005.
In his May 13, 2005 article, "Medtronic's Sprint Fidelis Defibrillator Lead Performance Update", Dr. Wes provides us with a summary of and link to the May 7, 2008 Medtronic update on the recalled Sprint Fidelis Model 6949 defibrillator lead. Thereafter, he expresses this opinion:
The implications of these recommendations are far-reaching, for it now seems that the fault with the lead was not a physician implant technique problem as originally surmised, but rather a design flaw.
You should read this brief but informative May 13 post by Dr. Wes to see how he arrives at this opinion.
If, however, you want to do your own analysis of what caused the Sprint Fidelis defibrillator leads to malfunction or fail altogether, here's some material for you to start with:
- October 15, 2007 Medtronic Letter: "Urgent Medical Device Information Sprint Fidelis® Lead Patient Management Recommendations"
- May 7, 2008 Medtronic Letter: "Sprint Fidelis® Lead Performance Update (Models 6949, 6948, 6931, 6930)"
Switching gears a bit -- for those of you who have not heard the bad news, yet -- on February 20, 2008 in the Riegel v. Medtronic case, the U.S. Supreme Court granted legal immunity to manufacturers of medical devices which had been approved by the FDA based on the legal doctrine of federal preemption.
But as Dr. Robert Hauser, of the Minneapolis Heart Institute, told a news reporter who was preparing a story about the Sprint Fidelis recall: "Just because a device is FDA-approved does not necessarily mean it is safe."
It is my opinion that Congress should move quickly to pass legislation that would correct the Riegel decision by the Supreme Court.
This legislation is needed because, in my experience, the possibility of becoming involved in product liability litigation is a significant incentive for the medical device manufactures to ensure that their products are safe for use by American patients.
I would like to hear what you think about this issue as well as my opinion about use of the federal preemption doctrine in this context. You can do so by submitting a Comment, below, or by taking part in a poll on this issue -- "What if you were hurt by a drug and couldn't sue?" -- over on the HeyMonkeyBrain! part of Squidoo.
