Medtronic Says Broken Heart Wires Tied to 13 Deaths

-Bloomberg

03/14/2009 - Medtronic Inc. said fractures of wires in its cardiac defibrillators “may have been a possible or likely contributing factor” in 13 deaths, more than double the number initially suspected.

The cases were identified by an independent physician panel that reviewed 89 of 107 reports saying the wires, or “leads,” sold under the brand name Sprint Fidelis may have contributed to patient deaths, Medtronic said today in a letter to physicians. The Minneapolis-based company, the world’s largest maker of electronic heart devices, said “it is not possible” to determine the cause of death with certainty.

Medtronic halted sales of the defibrillator leads in October 2007, saying five deaths may have been linked to the fractures of the devices. The panel’s report is its first assessment of patient use since then. In January, Medtronic won dismissal of defibrillator-related lawsuits related to the wire fractures that had been consolidated in a U.S. District Court in Minnesota.

“The panel noted that four of the 13 deaths were associated with lead extraction, highlighting the risks associated with that procedure,” the company said in its letter to doctors said. “With the exception of the appearance of deaths associated with lead extraction, no new or unexpected trends have been observed.”

Market Share

Medtronic had more than 50 percent of the $5.8 billion global market for defibrillators before sales of the Fidelis Sprint leads were halted. The company’s share slid to 48 percent in its fiscal third quarter reported last month, William Hawkins, Medtronic’s chief executive officer, said then.

Medtronic fell as much as 4.2 percent to $27.38 in extended trading on the New York Stock Exchange. Earlier, the company’s shares rose $1.42, or 5.2 percent, to close at $28.58 at 4 p.m.

The Sprint Fidelis wires deliver electrical jolts from stopwatch-size defibrillators implanted in the chest to regulate faltering heartbeats. The leads are threaded into arteries and the heart.

About 268,000 Sprint Fidelis leads have been implanted worldwide, Medtronic said.

The panel recommended against removing leads as a safety precaution only, without some evidence that the wires might be faulty, said Christopher Garland, a Medtronic spokesman, today in a telephone interview. The panel “was very strong on this, that there should not be prophylactic removal” of the leads, he said.

The panel recommended that removal of faulty leads “be performed by a physician with extensive lead extraction experience,” the company said. Patients who experience “unexpected shocks” from the devices should contact their physicians immediately, the company said.

The panel’s recommendations “are reasonable and conservative” and need to be “continuously updated,” Mark Estes, a Boston cardiologist who is president of the Heart Rhythm Society, a Washington, D.C.-based cardiologist group, said today in a telephone interview.

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