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Statement by Daniel Schultz, M.D., director of the Center for Devices and Radiological Health:

Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.

These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.

Defibrillators are life-saving products for patients with a heart rhythm abnormality. We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect. However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.

Background:
Today, Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.

Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today's action.

Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.

When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.

Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don't know if this rate of adverse events will remain constant or increase over the life of these leads.

FDA considers Medtronic's action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action. We recognize that some patients and health care professionals might inappropriately interpret the word "recall" to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.

The leads continue to function properly in the vast proportion of patients. Although there is no test to predict which lead will fracture, FDA agrees with Medtronic's recommendation that defibrillator settings be adjusted at the patient's next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed.

Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.

Patients should recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients have reason to believe that they have a Sprint Fidelis lead or if they do not know the model of their lead, they should contact their health care professional.

FDA will continue to monitor information on these devices and will take whatever other actions may be necessary.

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Medtronic Halts Distribution of Defibrillation Leads

Oct. 15 (Bloomberg) -- Medtronic Inc., the world's largest maker of electronic heart devices, stopped selling wires that connect implantable defibrillators to the heart and projected lower revenue. The stock fell the most in more than 24 years.

Medtronic suspended sales of the Sprint Fidelis devices globally, saying they may have caused five deaths. The wires, called leads, may break or erode, the Minneapolis-based company said today in a statement. The withdrawal of the leads may hurt sales of the $30,000 defibrillators, especially in Japan.

Revenue this quarter will be reduced by $250 million, or 7 percent, based on the average estimate of analysts surveyed by Bloomberg. The recall is another setback for the $5.6 billion implantable defibrillators market, which shrank after Medtronic and competitors recalled faulty products in 2005. The withdrawn wires have been used in more than a quarter-million people.

``Medtronic is at risk of losing market share,'' said Daniel Owczarski, an analyst with Soleil-Belmont Harbor Research in Chicago, in a telephone interview. ``This headline is definitely concerning.'' Owczarski rates Medtronic a ``buy'' and doesn't own any shares.

The company captures about half the defibrillator market worldwide, said Rob Clark, a company spokesman, in a phone interview today. Its largest rivals are Guidant, acquired by Natick, Massachusetts-based Boston Scientific in 2006 for $27.5 billion, and St. Jude Medical Inc. of St. Paul, Minnesota.

Medtronic dropped $6.79, or 12 percent, to $49.54 at 1:26 p.m. in New York Stock Exchange composite trading and earlier fell 14 percent. The stock fell 16 percent on Feb. 13, 1984.

Five Deaths

The company said it identified five patient deaths ``in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.''

The Sprint Fidelis leads deliver electrical jolts from stopwatch-sized defibrillators implanted in the chest to regulate a faltering heartbeat. The devices are used in people at risk of cardiac arrest, the biggest killer in the U.S.

More than 1 million people in the U.S. have heart conditions that make them susceptible to sudden cardiac death. Studies show defibrillators can reduce such fatalities by about 7 percent over five years.

Leads, which are metal, can fail over time, said Bruce Wilkoff, a cardiologist and specialist in electronic heart devices at the Cleveland Clinic, in an interview. The leads cost about $1,000 to $3,000, excluding the cost of surgery, he said.

`Metal Fatigue'

``A wire, when it's bent and flexed a number of times, can break,'' Wilkoff said. ``It's metal fatigue. The body is a pretty hostile environment. Leads have always broken.''

Factors contributing to leads breaking include their design, how they're implanted and what types of physical activity patients pursue, he said. It's possible to determine whether the leads are failing without performing surgery. Failing leads can be replaced, or it's possible to add new ones, Wilkoff said.

Precautionary replacement isn't recommended because the danger of removal outweighs the risks of a wire failure, Medtronic said. The company already faces more than 900 lawsuits over defibrillators, some of which quit working without warning, customers have claimed.

``Given the number of patients with Sprint Fidelis leads that will have to be checked and possibly reprogrammed, we believe the adverse publicity will be significant,'' said Timothy Nelson, an analyst at Piper Jaffray & Co. in Minneapolis, in a note to investors.

Half the Market

Nelson said the number of patients is about the same as those affected by defibrillator recalls in 2005 by Guidant Corp., now a unit of Boston Scientific Corp.

``Patients can be assured that the likelihood of fracture is very low and the U.S. Food and Drug Administration is committed to ensuring that the risk to patients is minimized,'' said Daniel Schultz, the agency's director of the Center for Devices, in an e-mailed statement today.

The Sprint Fidelis lead is the only such device that Medtronic has approved in Japan, said Chief Financial Officer Gary Ellis in a conference call with investors today. Medtronic said it won't be able to replace the recalled product in other countries with its only alternative, the Sprint Quattro, until later this fiscal year because of limited supply.

The fracture rate on the Sprint Fidelis wires is 2.3 percent at 30 months, compared with 1 percent on average for other Medtronic leads, Piper Jaffray's Nelson wrote. Depending on location, a break can result in failure to shock or pace the heart, or battery failure, he said.

Loss of Output

Fractures in the Sprint Fidelis leads may lead to audible alerts, inappropriate shocks and the loss of output, Medtronic said. Patients with pacemakers aren't affected by the suspension, the company said.

Medtronic said it wrote to 13,000 doctors worldwide and made ``direct outreach'' with updated information on management of the leads in patients who have them. The recommendations include reprogramming instructions to ensure the defibrillator better monitors for potential problems.

``We take all matters of product quality very seriously and believe this action is the right thing to do, given currently available information,'' Medtronic Chief Executive Officer Bill Hawkins said in a statement.

An elevated fracture rate in the lead was first announced in March, he said.

``In the total course of leads and defibrillators, this will be a blip,'' said Douglas P. Zipes, a professor at Indiana University School of Medicine in Indianapolis, and a consultant to Medtronic, in an interview. ``It's not going to dramatically change what we do, or have a dramatic effect on Medtronic.''