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MEDICARE MAY FOOT BILL FOR PACEMAKERS

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Medicare may end up paying more than $50 million to replace faulty heart pacemakers, a congressional study says.

The General Accounting Office, the investigative arm of Congress, said Thursday that current law makes it too difficult and costly to sue those responsible for the defects to recover the money.About 103,400 patients received Medtronic Inc. pacemakers that later were recalled or had safety alerts placed on them, a GAO report said. More than 7,000 of those patients can expect that wires, or leads, on the devices will fail.

"We estimate that the minimum potential cost to the federal government through the Medicare program for additional medical services required by the possibly defective leads . . . is between $50 million and $56 million," the report said.

"Our analysis shows that the health risks associated with defective pacemaker leads are real; indeed their failure could prove fatal," the report said.

Medtronic spokesman Dick Reid called the $50 million "grossly overstated," saying the study overlooked the fact that most pacemaker patients are continually monitored by their physicians.

"Any complications are detectable during that monitoring session, usually far enough in advance that if there is a problem with a pacemaker lead, it can be replaced at the same time as the pacemaker when its battery expires," Reid said in Fridley, Minn.

Last summer, the Food and Drug Administration ordered companies making or importing pacemakers with implanted leads to study the devices' long-term performance.