Safeguards urged after recall of heart defibrillator lead

-Clarion Ledger

03/10/2008 - Airline passengers, cell-phone users and cable-TV customers enjoy more consumer protections than patients who have life-sustaining medical devices, a prominent cardiologist wrote recently in the New England Journal of Medicine.

Fridley, Minn.-based Medtronic Inc.'s recall of a popular heart defibrillator lead in October underscores serious flaws in the way government regulators track devices and the "urgent need" for legislation to protect consumers, according to Dr. William Maisel, director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston.

Maisel uses last year's recall of Medtronic's Sprint Fidelis heart defibrillator lead to illustrate his opinion piece, which is occasionally critical of the way the medical technology company and the Food and Drug Administration handled the matter.

"The narrative is incomplete and omits facts that are essential to any full accounting or analysis of the events and their ramifications," Medtronic said in a prepared statement.

Medtronic stopped selling the leads because some were found to fracture inside the body, which could cause the defibrillator to stop working or inappropriately shock patients, a sensation that feels like a kick in the chest. Five deaths may be linked to malfunctions.

Implantable cardioverter defibrillators are stopwatch-sized computers that shock an errantly beating heart back into rhythm. The devices consist of a pulse generator with a battery that is implanted beneath the collarbone, connected to the heart with two or three wire leads.

Maisel wrote that when the Sprint Fidelis lead was approved by the FDA in 2004, the device was never tested on humans, so there was no clinical data to show whether it was safe. Medtronic disputes that, saying that Sprint Fidelis was tested on 160 patients before it was sold in the United States.

The FDA permits this type of approval, but only if the device is similar to one already cleared by the agency - in this case, another Medtronic lead called Quattro.

That approval process is controversial in some circles.

"Congress needs to close the loophole that allows manufacturers to introduce new products that (support or sustain life) without full testing and peer review by an outside panel of experts," said Dr. Robert Hauser, senior consulting cardiologist with the Minneapolis Heart Institute Foundation and a critic of the FDA. "Fidelis highlighted the weakness of the current regulation."

Ennis & Ennis, P.A. is representing individuals that have been harmed by defective medical devices such as the Medtronic defibrillator and pacemaker. If you or a loved one have suffered as a result of a defective Medtronic pacemaker or defibrillator or if you need more information about the Medtronic recall or class action lawsuit click here for a free, confidential case evaluation.