Source | Wall Street Journal

By ANNA WILDE MATHEWS and THOMAS M. BURTON

Medtronic Inc.’s decision to stop selling potentially defective defibrillator leads has prompted scrutiny of the devices and of how safety concerns about them were handled by the company and the Food and Drug Administration.

Plaintiffs attorneys, a consumer group and Iowa Sen. Chuck Grassley are examining the history of the Sprint Fidelis leads, which are electrical wires that connect the hearts of patients to the defibrillators implanted in their chests.

Full Article

Learn More About the Medtronic Sprint Fidelis Recall 

Medtronic has suspended sales of the Sprint Fidelis® family of defibrillator leads because of the potential for lead fractures, reports of at least 5 patient deaths and other serious, life-threatening complications.

S&C Resources 

Medtronic Recall Information

Sprint Fidelis Recall Information

Medtronic Inc. stopped selling the Sprint Fidelis lead wires that connect implantable defibrillators to the heart today (11/15/07).Medtronic has stated that the Sprint Fidelis device may have caused five deaths. The wires, called leads, may break or erode causing death or other serious life-threatening complications.

Source | Emily Brown with Bloomberg.com

5 Deaths

Medtronic said it identified five patient deaths “in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.'’

According to Bloomberg, 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.'’

Source | Associated Press

WASHINGTON - Medtronic Inc. has suspended distribution of its Sprint Fidelis defibrillation leads after identifying five patient deaths in which a lead fracture may have been a contributing factor.

A defibrillator monitors a patient’s heartbeat; if it senses an abnormal heart rhythm, it delivers an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device implanted near the shoulder with one or more leads connecting the device to the heart.

Medtronic said Monday it had discovered a “small chance of fractures in particular locations” on Sprint Fidelis models 6930, 6931, 6948 and 6949. The company is asking doctors to stop implanting the leads and return all unused leads to Medtronic.

A fractured lead “can cause the defibrillator to deliver unnecessary shocks or not operate at all,” said Daniel Schultz, director of the Food and Drug Administration’s Center for Devices and Radiological Health.

The company is not recommending that patients with such a lead have it removed, since they “are more likely to experience complications from removal.” Instead, Medtronic said, doctors can reprogram the device to alert the patient that a fracture may have occurred. Possible indicators could include audible alerts or inappropriate shocks.

“We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect,” Schultz said. “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.”

More than 268,000 of the leads have been implanted. Medtronic and the FDA estimated that fractures have occurred in less than 1 percent of those leads.

Medtronic senior vice president Pat Mackin emphasized that the company’s action does not apply to Medtronic pacemakers.

Medtronic advises patients with Sprint Fidelis leads to contact their doctor’s office. Patients who are unsure about whether they have a Sprint Fidelis lead can contact Medtronic Patient Services at 1-800-551-5544, extension 41835, or visit http://www.medtronic.com/fidelis.

Do I have a Sprint Fidelis® Lawsuit?

The Medical Device and Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Sprint Fidelis® lawsuits. We are pursuing individual litigation nationwide and currently accepting new Sprint Fidelis® defibrillator lead cases in all 50 states.

If you or a loved one have been injured by the Sprint Fidelis® Lead, you should contact us immediately. You may be entitled to compensation and we can help.

Source | FDA

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.

#

Manufactured by Medtronic, Inc., Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur.

Defibrillators monitor heart rhythms. They deliver an electrical shock or rapid pacing to restore normal rhythm when life-threatening, irregular heartbeats are detected. These devices keep the heart from going too fast. They are surgically implanted for patients who are at risk of sudden cardiac arrest.

Medtronic, Inc., is announcing that it is voluntarily suspending worldwide distribution of the Sprint Fidelis family of defibrillation leads. This includes four Sprint Fidelis Models: 6930, 6931, 6948, and 6949. FDA considers this removal action to be a medical device recall. Medtronic is advising physicians to stop implanting the leads and to return unused products to the firm.

You may have a patient card that identifies the implanted devices you have. If you have any uncertainty about your devices, you should contact your physician.

This action does not affect patients who have Medtronic devices that are pacemakers. While defibrillators keep the heart from going too fast, pacemakers keep the heart from going too slowly. This action also does not affect patients who have Medtronic ICDs or CRT-Ds without a Sprint Fidelis lead.

A recall is an action taken when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A recall for an implantable medical device does not always mean that the device has to be removed.