150,000 People in the U.S. Have Been Implanted with Defective Medtronic Defibrillator Cables
April 7th, 2009If you think that Medtronic is going to get nailed to the wall with endless lawsuits over this… Guess again!
Via: New York Times:
Consider the Sprint Fidelis, a heart defibrillator cable. In 2007 its maker, Medtronic, stopped selling it after five patients who had the cables died.
But only now is the full scope of the public health problem becoming clear for the Sprint Fidelis, which is still used by 150,000 people in this country.
In the next few years, thousands of those patients may face risky surgical procedures to remove and replace the electrical cable, which connects a defibrillator to a chamber of the heart.
Medtronic estimates that the cable has failed in a little more than 5 percent of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.
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Medtronic has been shielded so far from legal claims over the recalled device. More than 1,000 patient lawsuits involving the Sprint Fidelis have been thrown out because of a ruling last year by the Supreme Court. The court held in a ruling involving a different medical device that federal law protects device makers from liability suits involving some products, as long as the F.D.A. has approved their products.
Some Democrats in Congress have vowed to pass legislation that would override the Supreme Court decision. They cite the Sprint Fidelis problem as one reason, also noting the F.D.A. let it onto the market without extensive testing.
Medtronic is supplying replacement cables, but the cost of the operation to implant a cable, which can run $15,000 to $20,000 is being borne by Medicare or private insurers.
