Maker Halts Sale of Heart Implant Component

Source: New York Times

By BARNABY J. FEDER
Published: October 15, 2007

The nation’s largest maker of implanted heart devices, Medtronic, said yesterday that it was urging doctors to stop using a crucial component in its most recent defibrillator models because it was prone to a defect that has caused malfunctions in hundreds of patients and may have contributed to five deaths.

The faulty component is an electrical “lead,” or a wire that connects the heart to a defibrillator, a device that shocks faltering hearts back into normal rhythm. The company is urging all of the roughly 235,000 patients with the lead, known as the Sprint Fidelis, to see their doctors to make sure it has not developed a fracture that can make the device misread heart-rhythm data.

Such a malfunction can cause the device to either deliver an unnecessary electrical jolt or fail to provide a life-saving one to a patient in need. In most cases, the defibrillators can be reprogrammed without surgery to minimize the problem.

Medtronic estimated that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. Those patients will require a delicate surgical procedure to replace the lead, experts said.

Medtronic said it would stop selling the lead and recall all leads not yet implanted.

Replacing leads on a heart device like a defibrillator is considered by experts to be far more dangerous than replacing the device itself. As a result, doctors said that patients were better off leaving the lead in place except in those instances where it has stopped functioning properly....

Vice President Dick Cheney uses a Medtronic defibrillator, but it was implanted in 2001, before the Fidelis lead was introduced. The White House declined to comment last night....

Read more: http://www.nytimes.com/2007/10/15/business/15device.html?hp

God works in mysterious ways....but I'd like to hope!

:dunce:

the reason it becomes so tricky to remove is that the lead rests directly upon the heart muscle, and becomes embedded in the heart itself.

"Replacing leads on a heart device like a defibrillator is considered by experts to be far more dangerous than replacing the device itself. As a result, doctors said that patients were better off leaving the lead in place except in those instances where it has stopped functioning properly...."

I used be involved in doing them. There's nothing unusually dangerous about it. It's just that any invasive procedure like a cath should be minimized. Basically they would just retrieve the old lead and screw in a new one.

I don't know how this got past the FDA. I'm guessing it's a fatigue failure with the wire lead. But that's a totally blind guess.

The cath procedure consists of hospital time and prep work. It's tens of thousands of dollars just to roll in that lab on a gurney.

This doesn't bode well.