F.D.A. Tests on Devices Scrutinized

-NY Times

10/23/2007- A Congressional committee notified the Food and Drug Administration yesterday that, as a result of a recall by Medtronic of a product linked to patient deaths, it was reviewing how rigorously the agency required heart device components to be tested.

In a letter to the agency, Representative Henry A. Waxman, Democrat of California and chairman of the Committee on Oversight and Government Reform, asked agency officials a series of questions about its oversight of leads, the wires that carry electrical information between an implanted defibrillator and the heart.

Among other issues, Mr. Waxman asked the agency to provide information about how it determines how much to test leads before marketing and why the agency does not give leads the same scrutiny that it has given in recent years to defibrillators. A defibrillator is an implanted device that sends out a jolt of electricity to restore a chaotically beating heart to normal rhythm.

Karen Riley, a spokeswoman for the F.D.A., said that the agency had yet to see the letter and could not comment on it.

When it issued the recall last week, Medtronic disclosed that a widely used lead produced by the company was fracturing, disrupting or preventing the flow of electricity between the heart and a defibrillator.

The company has said that at least five patients may have died as a result of the defect and that thousands more would need to undergo operations to correct it.

Some specialists said they believed the Medtronic lead, which was introduced in 2004, was prone to fracturing because it was the thinnest lead ever made by the company and might not have been durable enough.

Megan Moynahan, a branch chief at the F.D.A. Center for Devices and Radiological Health, said last week that the agency was reviewing whether to require more strenuous laboratory testing of such products before they go on the market.

Defibrillator leads are known to fracture, but neither the F.D.A. nor device makers have developed effective ways to track such episodes.

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