Medtronic Lawsuit Dismissed News | Medtronics Recall Attorneys

In January 2009 the United States District Court ruled the Sprint Fidelis Medtronic Lawsuit Dismissed. This ruling is currently under appeal and attorneys representing patients and families affected by the Medtronic recall continue to fight for their rights. The Medtronics recall involves only the Sprint Fidelis lead and not the implanted heart device.

The defibrillator lead models affected by this recall are: 6930, 6931, 6948 and 6949. The easiest way to find out if your lead has been recalled is to check your patient ID card or wallet card. Under Model #, look for any of the following numbers: 6930, 6931, 6948 or 6949. Any of these numbers indicates you have a recalled lead. If you have one of the recalled leads, it is important you contact your doctor, especially if you have suffered multiple shocks, lightheadedness, fainting or palpitations.

According to Medtronic, since 2004 approximately 268,000 Medtronic Sprint Fidelis defibrillator leads have been implanted worldwide. Currently, according to the New York Times, it is estimated that around 150,000 U.S. patients are still implanted with a Sprint Fidelis Medtronic heart lead.

The FDA is not recommending routine removal of the device. If your lead is not fractured, then the FDA recommends that the defibrillator program settings be adjusted so that the device will provide early warning beeps when there is a change in the lead impedance. Replacing a lead poses such serious risk that the FDA and many physicians recommend continued use of the lead with careful monitoring of its performance.

If your Sprint Fidelis lead is fractured, then there are a couple of options your doctor will discuss with you. One option is surgical extraction of the fractured lead. However, surgical removal has serious risks and complications. At least four people have died during the extraction process. The risks related to surgical extraction include infection, puncturing or tearing of the heart, tissue, veins or vessels and potential damage to the heart valve. Doctors often prefer to implant a replacement lead model and cap off the old lead by covering the tip with a small plastic insulation so that the fractured lead is still in place, but no longer functional.

Medtronic, in its March 2009 Physician Letter, explains that factors to consider when making the decision to extract and implant a new lead should include “patient life expectancy, age and co-morbidities, number of implanted leads and duration of implant, and patient preference.” The letter further states that “Medtronic’s Independent Physician Quality Panel recommends that if a lead requires removal, the procedure be performed by a physician with extensive lead extraction experience.”

We represent all Medtronics recall clients who suffered a lead fracture or failure on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation case review please call toll free or fill out our short online contact form and a Medtronic lead lawsuit attorney will contact you to answer any of your questions.

Medtronic Lawsuits News | Medtronics Recall Attorney Lawyer

Medtronic lawsuits continue to be filed on behalf of patients affected by the Sprint Fidelis Medtronics recall. Implantable Cardioverter-Defibrillators (ICDs) are implanted heart devices that shock dangerous abnormal heart rhythms back to a normal rhythm. The lead is a wire that connects the ICD to the heart. Medtronic, Inc., a Fortune 500 company based in Minnesota, manufactured Sprint Fidelis Leads, which 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.

On October 15, 2007, Medtronic, Inc. announced that it was voluntarily suspending worldwide distribution of the Sprint Fidelis family of defibrillation leads after receiving reports of five (5) fatalities linked to lead fractures. This included four Sprint Fidelis Models: 6930, 6931, 6948, and 6949. The Food and Drug Administration (FDA) considered this removal action to be a medical device recall. The recall pertains to the Sprint Fidelis lead only, not the implanted defibrillation or pacemaker device. These leads were recalled because of the potential for lead failure. These electronic wires are prone to fracture in a small number of patients. When the lead breaks (fractures), it may cause inappropriate shocks or result in a loss of therapy, such as pacing or shocking. Some deaths and other serious injuries have been reported in which a fracture in a Sprint Fidelis lead may have been a possible or likely contributing factor.

Approximately 268,000 Fidelis leads have been implanted worldwide, including 172,000 Sprint Fidelis leads implanted in the United States. At the time of the recall, Medtronic had confirmed 665 chronic fractures in returned leads and estimated that about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. As of March 13, 2009, the FDA’s MAUDE database, which contains reports of adverse events involving medical devices, had 107 Medical Device Reports (MDRs) that include allegations that the Fidelis lead may have caused or contributed to a patient’s death.

Unfortunately, there is no reliable way to test whether a lead may fracture. The FDA recommends that patients who have had the Sprint Fidelis lead implanted immediately contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Routine removal is not recommended by the FDA or Medtronic as the risks of removal in most patients exceed the small risk of lead fractures. Therefore, it is generally recommended to leave functioning leads in place.

However, there are two alternatives to removing the lead, neither of which is particularly comforting to a patient with the device. One is to continue using the lead while monitoring closely for signs of fracture. The other is to surgically add a replacement lead, which does not require removing the Sprint Fidelis lead but does require that it be capped or covered with a small plastic insulation.

We represent all Medtronics recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic lawsuits attorney will contact you to answer any of your questions.

We are continuing to fight for patients rights who have been affected by the Medtronic recall of Sprint Fidelis leads.

Medtronic Recall News | Medtronics Lawsuit | Medical Device Safety Act Legislation Update 2009

Since the Medtronic recall of Sprint Fidelis heart leads in October 2007, patients are continuing to suffer from the life threatening consequences of a fractured defibrillator lead with no real legal recourse. Following the 2008 Supreme Court decision Riegel v. Medtronic, patients and families have been prevented from having the right to file a viable Medtronics lawsuit to help cover medical bills, lost wages and pain and suffering based on FDA preemption. In the 2008 case, the court decided that the Food, Drug, and Cosmetic Act preempts (prevents) state-law damages lawsuits brought by patients who have been injured by medical devices (like the Medtronic Sprint Fidelis leads) that were approved by the Food and Drug Administration (FDA).

We are continuing to fight for patients who have been affected by the Medtronic recall of Sprint Fidelis leads, however this legislation is very important for patients who have already suffered from a broken lead along with patients of other medical devices.

On May 12, 2009 there was a hearing on H.R. 1346, the Medical Device Safety Act of 2009. This legislation would overturn the 2008 Riegel Supreme Court decision and allow patients injured by medical devices the right to bring a claim for compensation. This legislation would also help remove harmful medical products from the market even if they were initially approved by the FDA. This benefits all patients by helping make sure that safe medical products are in the marketplace. The Medical Device Safety Act is vitally important for victims of defective Medtronic defibrillator leads who are currently left without any meaningful legal options and patients in general who use FDA approved medical devices.

The following are links to the House of Representative testimony along with video of the hearing.

• David Vladeck, J.D., Professor of Law, Georgetown University Law Center
• William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute
• Gregory Curfman, M.D., Editor, New England Journal of Medicine
• Bridget Robb, Gwynedd, Pennsylvania
• Richard Cooper, Partner, Williams & Connolly LLP
• Michael Kinsley, Seattle, Washington

We represent all Medtronic recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronics lawsuit attorney will contact you to answer any of your questions.

We are continuing to fight for patients rights who have been affected by the Medtronic recall of Sprint Fidelis leads.

Medtronic Fidelis Lead Recall News | ICD Failure Defibrillator Problems Information

Sprint Fidelis leads are manufactured by Medtronic, the medical device manufacturer headquartered in Minnesota. The Medtronic Fidelis lead consists of cardiac electrodes which are thin wires. These electrodes connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart.

The Medtronic Fidelis leads recall was announced by the manufacturer and the FDA due to the potential for lead fractures or ICD failure. Following reports of fractured leads and at least 5 patient deaths caused by defibrillator problems, Medtronic recalled their Sprint Fidelis defibrillator leads. Patients may be at an increased risk of having their leads fracture or break. If this happens the defibrillator could deliver painful shocks or jolts or fail to operate at all.

Overview of ICD defibrillator/leads

For life-threatening cardiac arrhythmias that include ventricular fibrillation (chaotic heartbeat) and ventricular tachycardia (dangerously fast heartbeat), defibrillation is the definitive treatment, consisting of delivering a therapeutic dose of electrical energy to the affected heart with a device called a defibrillator. This dose of energy depolarizes a critical mass of the heart muscle, terminating the arrhythmia and allowing normal sinus rhythm to be reestablished by the body’s natural pacemaker in the sinoatrial node of the heart.

Types of Defibrillators

Defibrillators can be external, transvenous, or implanted, depending on the type of device used or needed.

Manual external defibrillators are used in conjunction with electrocardiogram readers, which the healthcare provider uses to diagnose a cardiac condition. The healthcare provider will then decide what charge (in joules) to use, based on proven guidelines and experience, and will deliver the shock through paddles or pads on the patient’s chest. As they require detailed medical knowledge, these units are generally only found in hospitals and on some ambulances.

Automated external defibrillators (AEDs), automate the diagnosis of treatable rhythms, meaning that lay responders or bystanders are able to use them successfully with little, or in some cases, no training at all. These units are based on computer technology that is designed to analyze the heart rhythm itself and then advise the user whether a shock is required. They are usually limited in their interventions to delivering high joule shocks for ventricular fibrillation and ventricular tachycardia rhythms, making them generally limiting for use by health professionals who could diagnose and treat a wider range of problems with a manual or semi-automatic unit. The automatic units also take time (generally 10-20 seconds) to diagnose the rhythm, where a professional could diagnose and treat the condition far quicker with a manual unit.

An implantable cardioverter-defibrillator (ICD), also known as an automatic internal cardiac defibrillator (AICD), is a pager-sized device similar to a pacemaker (and many can also perform the pacemaking function). They constantly monitor the patient’s heart rhythm to detect and stop dangerous abnormal heartbeats (arrhythmias) by automatically administering electrical shocks to restore a normal heart rhythm when necessary. Many modern devices can distinguish between ventricular fibrillation, ventricular tachycardia, and more benign arrhythmias like supraventricular tachycardia and atrial fibrillation.
Implantable Cardioverter-defibrillator (ICD)

The procedure to implant an ICD is usually relatively minor and typically takes one to three hours. It can be performed with numbing medication and a sedative that puts you in a relaxed state but allows you to remain aware of your surroundings. During surgery, a flexible, insulated wire (lead) is inserted into a major vein under or near your collarbone and guided, with the help of X-ray images, to your heart. The ends of the leads are secured to your heart’s bottom pumping chambers (ventricles), while the other ends are attached to the shock generator, which is usually implanted under the skin beneath your collarbone.

After implantation, your doctor will test your ICD and program it to treat your specific heart rhythm problem. Testing requires shocking your heart, which will require general anesthesia so that you are not awake during the test, and you will need to stay in the hospital one or two days. The ICD may be evaluated one more time before you are discharged but any additional tests of your ICD usually do not require surgery.

An ICD is usually programmed to perform these functions:

• Cardioversion. If the ICD detects a dangerously fast heartbeat, it delivers an electrical shock that converts the fast heartbeat into a slower, normal heartbeat.
• Defibrillation. If cardioversion fails and your heartbeat either quickens or beats chaotically, or sometimes a chaotic heartbeat develops spontaneously, the ICD delivers a stronger electrical shock that resets (defibrillates) your heart to start beating normally.

An ICD can also be programmed to perform anti-tachycardia pacing, anti-bradycardia pacing, biventricular pacing or record heart activity.

You are a prime candidate for an ICD if you have had ventricular tachycardia, survived a cardiac arrest or have fainted from a ventricular arrhythmia. You may also benefit from an ICD if you have a history of coronary artery disease and prior heart attack that has led to a weak heart; a heart condition that involves abnormal heart muscle, such as enlarged (dilated cardiomyopathy) or thickened (hypertrophic cardiomyopathy) heart muscle; or you have an inherited heart defect that makes your heart beat abnormally.

We represent all Medtronic Fidelis lead clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic recall attorney will contact you to answer any of your questions.

Medtronic Lead Recall News | Medtronics Lawsuit Lawyer

It is estimated there are 150,000 patients in the United States affected by the Medtronic lead recall who have a recalled defibrillator lead wire and are at risk of sudden death. The Medtronic Sprint Fidelis leads were removed from the market by Medtronic on October 15, 2007 due to the reporting of fractures in some wires and patients deaths associated with the defibrillator leads. Approximately 268,000 Medtronic leads were implanted in patients around the world. Medtronic’s Sprint Fidelis defibrillator leads were recalled because the leads (electronic wires) are prone to fracture or break causing major complications and the potential for patient fatalities.

Medtronic Sprint Fidelis Lead Fracture May Be Increasing

A recent study by Dr. Robert Hauser and Dr. David Hayes titled “The Increasing Hazard of Sprint Fidelis Implantable Cardioverter-Defibrillator Lead Failure” analyzed Medtronic lead failure rates compared to other ICD leads currently implanted in patients. They reported that the risk of failure of Sprint Fidelis leads was much higher compared to other defibrillator leads after the first year. The researchers reported that the most recent evidence shows the trend of Medtronic lead fractures increasing over time.

Medtronic’s current recommendation for patients is that they monitor them for lead fractures as opposed to having the leads replaced. This is due to the serious risks and complications associated with lead extraction surgery. A disturbing finding of the research was that 50% of patients received inappropriate shocks when their Sprint Fidelis leads failed. These shocks are extremely painful and many patients suffer from psychological effects due to the trauma of being shocked multiple times following a lead fracture.

We represent all Medtronic lead recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronics lawsuit attorney will contact you to answer any of your questions.

Sprint Fidelis Lead Wire | Medtronic Class Action News

The following patient letter from Medtronic follows increasing information that questions the safety of its Sprint Fidelis leads. An estimated 150,000 heart patients in the United States have implanted Sprint Fidelis leads that were subject to the 2007 Medtronic recall. The Medtronic leads can fracture in a certain number of patients leading to unnecessary shocks or failing to deliver a therapeutic shock when needed. At least 13 patient deaths are thought to be linked to the recalled Medtronic lead wires.

Important Patient Information
Sprint Fidelis® Lead Performance

March 13, 2009

Re: Sprint Fidelis® Lead Performance Update (Models 6949, 6948, 6931, 6930)

Open Letter to Sprint Fidelis Lead Patients:

We recently published updated information on Sprint Fidelis leads for your doctor to review. The chance that there will be a problem with your Sprint Fidelis lead remains small. The information we make available to your doctor about Sprint Fidelis lead performance is more detailed, since he or she is in the best position to know how to manage your care in light of your specific health considerations.

As a reminder, a defibrillation system consists of a device implanted near the shoulder and one or more defibrillation leads connecting the device to the heart. This letter pertains to your Sprint Fidelis lead only, not your implanted heart device.

We will continue to actively monitor Sprint Fidelis lead performance and will publish that performance four times per year on Medtronic’s website for your doctor to review.

If you have questions about your Sprint Fidelis lead, please contact your doctor’s office. Medtronic Patient Services is also available to answer your questions. Please contact us at 1-800-551-5544, extension 41835, between 7 am to 6 pm, Central Time.

Sincerely,

Timothy Samsel
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management

We represent all Medtronic class action clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic recall lawyer will contact you to answer any of your questions.

Medtronic Lawsuit News 2009

There was good news this week for any patients or families who have suffered from a Sprint Fidelis lead fracture and filed a Medtronic lawsuit.

Health Leaders Introduce Legislation Reversing Supreme Court’s Medical Device Decision

U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the Energy and Commerce Committee, today introduced legislation in the House that will reverse a U.S. Supreme Court decision that denies injured patients the ability to seek compensation for their injuries and gives medical device makers blanket immunity.In February 2008, the U.S. Supreme Court, for the first time, immunized medical device companies from lawsuits brought by patients who are injured by certain medical devices. In Riegel v. Medtronic, Inc., the Court found that those claims are barred by a preemption clause included in the Medical Device Amendments of 1976 (MDA). This decision ignores both congressional intent and 30 years of experience in which federal regulation, through the U.S. Food and Drug Administration (FDA), and tort liability played complementary roles in protecting consumers from device risks.

The Court’s decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings. It also removed one of the industry’s most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians.

The Medical Device Safety Act of 2009 protects patients from dangerous and defective devices by correcting the Court’s flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved.

“Yesterday the Supreme Court rightfully upheld a patient’s right to legal recourse after sustaining an injury from a pharmaceutical product,” Pallone said. “Today, we introduce legislation that gives patients that same right when injured by a medical device. This legislation puts safety first and eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year. We introduce this legislation today with strong bipartisan support, and I look forward to moving it through my subcommittee quickly.”

“As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety,” said Chairman Waxman. “The Court noted that these lawsuits ‘uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.’ The same is true for medical devices. We must act quickly to enact this important legislation that will restore the ability of patients injured by defective medical devices to seek compensation, and realign the incentives for manufacturers to ensure the ongoing safety of their products.”

The Court premised its decision on the theory that approval by the FDA adequately protects patients from unsafe medical devices, but the two lawmakers said that theory has proven false time and again. They point to numerous recent stories of patients who have suffered serious injuries from defective FDA-approved devices or devices without adequate safety warnings, like implantable cardiac defibrillators and pacemakers.

The Medical Device Safety Act of 2009 is endorsed by the National Conference of State Legislatures, the New England Journal of Medicine, the American Bar Association, AARP, the Center for Justice & Democracy, Consumer Federation of America, Consumers Union, Homeowners Against Deficient Dwellings, National Association of Consumer Advocates, National Consumers League. OWL – The Voice of Midlife and Older Women, Progressive States Network, Public Citizen, and the National Research Center for Women & Families

A companion bill has been introduced in the U.S. Senate by Sens. Edward Kennedy (D-MA), Chairman of the Senate Health, Education, Labor & Pensions Committee, and Patrick Leahy, Chairman of the Senate Judiciary Committee.

We represent all Medtronic recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic lawsuit attorney will contact you to answer any of your questions.

FDA Medtronic Recall Updates | Medtronics Lawsuit News

Following the latest court decision involving preemption in the Medtronics lawsuit for the recalled Sprint Fidelis leads it is interesting to see the increasing number of reports regarding the inner-workings at the Food and Drug Administration. According to a recent New York Times article, nine government scientists complained to the FDA commissioner regarding FDA managers and their lenient relationship with corporations seeking approval for medical devices.

Internal documents and medical reviews reveal that the agency scientists were critical of the medical device approval process that they felt lacked adequate testing of medical devices. In one specific example, the scientists alleged that an agency supervisor pressured them to change reviews of a breast imaging device among others. The increasing information regarding the inability of the FDA to adequately evaluate medical devices such as the recalled Medtronic Sprint Fidelis leads and drugs is especially disturbing considering that the medical device and pharmaceutical industry has been using the FDA approval process as a shield from any liability for products that turn out to be dangerous.

Sprint Fidelis leads are manufactured by Medtronic, the medical device manufacturer headquartered in Minnesota. Medtronics leads consist of cardiac electrodes which are thin wires. These electrodes connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart.

The Sprint Fidelis leads recall was due to the potential for lead fractures. After reports of fractured leads and at least 5 patient deaths, Medtronic recalled their Sprint Fidelis leads. Patients may be at an increased risk of having their leads fracture or break. If this happens the defibrillator could deliver painful shocks or jolts or fail to operate at all.

We represent all Medtronic recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronics lawsuit attorney will contact you to answer any of your questions.

Medtronic Leads Recall | Medtronics Recall Updates

Medtronic Lead Fractures Monitoring

Medtronic has announced a monitoring program to help detect a lead failure in patients affected by the Medtronic leads recall. The program is called “Lead Integrity Alert” and is supposed to improve detection of lead fractures. The monitoring program has three primary goals for patients with defective Sprint Fidelis leads.

Less Shocks
• Alert triggered by two different scenarios: 1) oversensing coupled with nonsustained VT and 2) a fixed impedance
• Safely automatically extends the VF detection NID to 30/40, once alert is activated

Improved Monitoring
• Continuously monitors lead integrity-24/7
• CareAlert^TM sent to clinic from wireless devices

Advance Warning
• 76% of patients receive a minimum of 3 days’ notice to seek medical attention1
• Audible alert sounds immediately, every 4 hours, and at the programmed time

1 Swerdlow CD, Gunderson BD, Stadler RW, et al. Inappropriate shocks due to Sprint Fidelis® ICD lead fracture may be reduced by programming more intervals for detection of ventricular fibrillation. Heart Rhythm. 2008;5(Supp 5S):S33. Presented Abstract: AB16-5.

Defective Medtronic Leads

Researchers, including Dr. Charles Swerdlow, developed a downloadable algorithm to help prevent inappropriate shocks in patients caused by defective Medtronic Sprint Fidelis leads. The algorithm can be downloaded into currently implanted cardioverter-defibrillators to detect lead fractures and alert the patient or their doctor before there is an inappropriate shock. In testing the new algorithm on data from 15,970 patients, it provided at least a 3 day warning in 76% of cases.

We represent all Medtronics recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic leads recall attorney will contact you to answer any of your questions.

Medtronic Lead Wire | FDA Approval New Defibrillator Lead

Medtronic has received FDA approval for a new defibrillator lead – the Sprint Quattro Secure lead. Last October, a Medtronic recall of its Sprint Fidelis leads was announced following reports of several patients’ deaths due to lead fractures. The following is Medtronic’s announcement of their new defibrillator heart lead.

Medtronic Announces FDA Approval and Market Availability of Sprint Quattro Secure® S Single Coil Defibrillation Lead

MINNEAPOLIS – Dec. 3, 2008 -Medtronic, Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Medtronic Sprint Quattro Secure® S single coil defibrillation lead (Model 6935) for use with implantable defibrillators in patients at risk for dangerous tachyarrhythmias (fast heartbeats) and sudden cardiac arrest. This new defibrillation lead is an addition to the Sprint Quattro® family that is supported by more than seven years of post-market performance data¹. It provides an option for physicians who prefer a specific type of lead for patients with unique anatomies and is designed to help reduce tip pressure. The U.S. approval and market release of this single coil option follows its recent European approval and launch.

The Medtronic Sprint Quattro Secure S lead is designed with an 8.6 French diameter lead body (approximately 2.8 millimeters in diameter). A thin wire inserted into the chambers of the heart through blood vessels, the lead is compatible with any Medtronic implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), which are stopwatch-sized devices that administer electrical shocks or painless pacing therapy to stop dangerous ventricular arrhythmias.

” I prefer a single coil lead for my patients and am looking forward to having this new option available,” said Michael Lincoln, M.D., with Holy Cross Hospital in Silver Spring and NIH Heart Center at Suburban Hospital in Bethesda, Md. “Based on my own clinical experience and the breadth of long-term clinical performance data, I believe the Sprint Quattro family of defibrillation leads is highly reliable.”

“The Sprint Quattro family of defibrillation leads is highly respected in the cardiac community,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “We are pleased the FDA has approved this single coil option, which gives physicians another choice in order to deliver the appropriate treatment to each individual patient.”

In conjunction with this introduction, Medtronic is extending its defibrillation lead warranty to a lifetime limited warranty, which covers all defibrillation leads implanted in the United States on or after Dec. 1, 2008. Under the lifetime warranty, Medtronic will provide a replacement lead at no charge if the lead does not perform according to specification and meets other specified warranty criteria. It also will reimburse patients for certain unreimbursed medical expenses in the amount specified in the warranty. Defibrillation leads implanted before Dec. 1, 2008 are covered by Medtronic’s current five-year limited warranty. Medtronic has offered a lifetime limited warranty on pacing leads in the United States since 1984.