Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Medtronic Inc. has issued a letter to doctors stating that a defective lead wire in its popular heart defibrillator, which was recalled in October 2007, may have contributed to the deaths of 13 individuals in which the heart devices were implanted, according to the Star Tribune. That death toll is up from the medical device company’s original estimate two years ago of five deaths.

In October 2007, Medtronic suspended the sale of many of its Sprint Fidelis Defibrillator leads after receiving reports of five fatalities connected with the devices. Fractures were found in devices which could cause them to unnecessarily shock patients or fail to work altogether.

The Sprint Fidelis leads connect electrical defibrillators to the hearts of patients with aberrant cardiac rhythms and deliver a jolt to the heart as needed to return the heartbeat to a normal rhythm. The defibrillators had been implanted in about 268,000 prior to the suspension, and an estimated 150,000 remain in U.S. patients today. Medtronic and many health experts have advised that the leads not be removed unless the device showed signs of fracturing, as removing the leads can put patients at serious risk.

In its letter to doctors, Medtronic says it hired a panel of independent physicians to study the issue and pore through 89 of the 107 reports sent to the Food and Drug Administration (FDA). The panel found that four of the 13 deaths occurred during procedures to remove the devices.

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