- The Washington Times - Friday, March 13, 2009

WASHINGTON (AP) - Medtronic, the world’s largest medical device maker, said Friday that 13 patients may have died as a result of problems with its heart device wires that were first disclosed in 2007.

The Minneapolis-based company pulled its Sprint Fidelis defibrillator leads off the market in October 2007 after identifying five patient deaths that may have been caused by the cracked wires.

In a letter sent to physicians Friday, Medtronic raised the number of estimated deaths to 13. The company notes that four of those deaths occurred when physicians tried to extract the wires. Medtronic has recommended patients leave the devices in because the risk of surgery may outweigh the risk of a device malfunction.

“This is likely to be the best choice for the majority of patients,” the company advised physicians.

Defibrillator leads connect patients’ hearts to implanted defibrillators that send an electrical shock if it senses a life-threatening abnormal heart rhythm. A fractured lead can prevent the device from sending a lifesaving shock or cause painful, unnecessary shocks.

Roughly 268,000 of the Fidelis leads have been implanted in patients worldwide, according to the company.

The Food and Drug Administration has received 107 reports of patient deaths where the devices may have played a role. Most of those reports were not filed by physicians, Medtronic notes, but “by family members or attorneys with minimal supporting data.”

After reviewing 89 of those reports, an outside group of physicians assembled by Medtronic judged that 13 deaths may have been caused by problems with the wires.

In recent months, federal judges have thrown out thousands of patient lawsuits against Medtronic, ruling that federal regulations shield the company from lawsuits filed at the state level. Those decisions were based on a Supreme Court decision last year that the federal FDA is the final arbiter of medical device safety.

Democrats in Congress are currently working to pass legislation to overturn that decision.

Shares of Medtronic fell $1.03, or 3.6 percent, to $27.55 in after-hours trading.

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