Medtronic stops selling heart device

In the wake of five deaths, Medtronic Inc. said today it has stopped selling a popular wire lead used with heart defibrillators because the lead may tear inside the body.

About 235,000 patients worldwide may be affected by the Fridley-based company's action. Patients who believe they may have the device implanted in their chest should contact their doctor, but Medtronic does not recommend replacing it.

The Food and Drug Administration (FDA) said it has classified Medtronic's action as a recall, which means Medtronic must stop selling the devices.

Part of a $5 billion global industry, a defibrillator is a device implanted in the chest that detects an irregular heartbeat and shocks the heart back into rhythm, warding off sudden cardiac death.

The lead, a key component of the heart-shocking system, is a flexible, insulated wire that is snaked through a vein in the chest.

It connects the device's stopwatch-size battery to the heart.

Medtronic has found that four models of its Sprint Fidelis lead, which is the industry's top-seller, tend to tear in a small number of cases. This could cause the device to stop working, emit a beeping sound or inappropriately shock patients -- a frightening and uncomfortable experience, but not life-threatening.

The company provided no further information about the circumstances or timing of the five deaths, saying only that they may have been related to the device.

Medtronic said that it pulled the leads off the market in the spirit of greater transparency following the recall of thousands of defibrillators in the past two years, primarily those made by rival Guidant Corp., which is now part of Boston Scientific Corp. Sales of the $30,000 device plunged following the recalls.

The previous high-profile recalls prompted questions about how quickly physicians and patients are informed of product malfunctions by device manufacturers and the FDA, and a number of changes aimed at better communication have occurred as a result.

"We are seeing much more transparency now than we did a decade ago," said Dr. Bruce Lindsay, a professor of medicine at Washington University School of Medicine in St. Louis, Mo., and president of the Heart Rhythm Society, a doctors' group. He advised Medtronic on the Sprint Fidelis recall communiqué.

Medtronic executives and doctors advising the company clearly are worried how patients will react to the news about the Sprint Fidelis leads. In the most recent defibrillator recalls, which involved the stopwatch-size batteries, many panic-stricken patients inundated doctors' offices with calls, pleading for their devices to be removed.

But removing leads from the body can be very difficult and cause significant complications, even death. Most defibrillators use two or three leads leading to the heart, and must be replaced at least every 10 years.

Medtronic estimates that surgery to remove a lead has a higher risk of complications and death (roughly 1.4 to 7.3 percent of surgeries have complications) than simply monitoring the Sprint Fidelis leads.

Based on the company's performance data, 97.7 percent of its Sprint Fidelis leads are still functioning properly 30 months after implantation, compared with 99.1 percent for the company's older, workhorse model, the Sprint Quattro lead. (Most doctors have preferred the Fidelis lead because it is thin and easy to use.)

Although the difference between the two models is not "statistically significant" now, Medtronic said the difference may grow significant over time. (Pacemaker patients are not affected by today's recall.)

"We think pulling the leads from the market is the right thing to do," said Dr. Daniel Schultz, director of the FDA's device division.

Doctors already alerted

The news will probably come as no surprise to doctors. In March, Medtronic sent a letter to physicians about the Sprint Fidelis tearing issue after an independent panel of doctors advised the company to do so.

In July, a Star Tribune article revealed that most key cardiologists in the Twin Cities who implant defibrillators had stopped using Sprint Fidelis leads anyway. Medtronic said a total of 268,000 leads have been sold worldwide since it was introduced in the fall of 2004. The device is made at a Medtronic facility in Puerto Rico.

Medtronic has sent letters about the problem to more than 13,000 doctors worldwide, as well as to patients with the device. The company is advising doctors following patients with Sprint Fidelis leads to reprogram the device. This may detect whether the wire is tearing, minimize or eliminate inappropriate shocks, and cause a beeping sound to emit from the device if there's a problem.

"I think we will be able to pick up potential problems with the leads even before they [tear]," said Dr. David Steinhaus, vice president and medical director for Medtronic's Cardiac Rhythm Disease Management business, which sells defibrillators and pacemakers.

Janet Moore • 612-673-7752

Janet Moore • jmmoore@startribune.com