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Medtronic suspended sales and recalled all unused Sprint Fidelis leads, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with defective Sprint Fidelis leads are being told to leave the components in place unless they fracture.
When Medtronic issued the Sprint Fidelis lead recall, it was estimated that about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. Apparently, it was a problem that the company had known about for months. Since it was introduced to the market in 2004, there have been 599 reports of lead fractures as of January 2007. And it seems as though the fracture problems became worse over time. In the first two months of 2006, there were 27 reports of the Sprint Fidelis lead fracturing. But in the first two months of 2007, there were 152 reports. And since January 10, 2007, there have been a staggering 1,030 reports of fractures.
Shortly after the Sprint Fidelis lead recall, it was learned that the FDA had not required extensive testing of the vital defibrillator component before it went on the market. Although the agency had required Medtronic to test an earlier version of a defibrillator lead in patients before approval, it had not required the company to do so for the defective Sprint Fidelis lead. That was because officials at the FDA had determined that the Sprint Fidelis lead was not a significant enough change from the design of its predecessor. Instead, the FDA required the Sprint Fidelis lead to pass only tests intended to identify design flaws. Those were principally mechanical stress tests meant to recreate the pressures in the body. The FDA is trying to figure out why those tests did not pick up the defects in the Sprint Fidelis lead.
Some medical experts have questioned the FDA’s decision not to put the defective Sprint Fidelis lead through more clinical tests. Though its predecessor, the Sprint Quattro, has a good performance history, the Sprint Fidelis lead is a significantly thinner wire. Many believe that thinness made the defective Sprint Fidelis lead more apt to fracture.
The issues that the Congressional Committee is investigating include the FDA’s decision not to subject the defective Sprint Fidelis lead to more rigorous testing, and why all defibrillator leads are not subject to the same level of scrutiny as the heart devices themselves.
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Medtronic Recall Latest Update:
Patients Warned as Maker Halts Sale of Heart Implant Part
by: The New York Times | Barnaby J. Feder
Tags: cardiac defibrillator,
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safety recall, sprint fidelis recall
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...
