13 deaths associated with Medtronic leads
Last week Medtronic acknowledged at least 13 deaths and about 2200 serious injuries that were tied to discontinued Sprint Fidelis leads, pulled from the market in October, 2007. Four of the deaths occurred during surgery to remove the leads. Recently disclosed FDA data indicated that Medtronic became aware of the problem with fractured leads soon after releasing the devices in 2004. 2000 legal claims have been filed against the company over the very thin, prone-to-fracture leads, however, at the moment it is protected from liability by a controversial Supreme Court decision that granted the manufacturer immunity. The immunity was conferred by FDA approval of the device, even though the approval was "grandfathered" upon prior approval of a different device with thicker wires, less prone to fracture.
It is believed that the Fidelis leads were implanted in about a quarter million people, with thousands receiving them after the company was fully alert to, and investigating the fracture problem. Some 150,000 people still have implanted leads, and surgeons stress that if they are to be removed, the removal should occur at a facility that handles a high volume of these surgeries.