Medtronic Heart Lead
Recall FAQ

Frequently Asked Questions about the Medtronic Heart Lead Recall

Lieff Cabraser represents persons across America injured by the Medtronic Sprint Fidelis heart lead. To contact an experienced injury attorney for a free case evaluation, please click here or call us toll-free at 1-800-948-2181.

Lieff Cabraser has successfully represented hundreds of patients across America who received faulty or recalled medical devices, including implantable cardiac defibrillators and pacemakers.

1. What is a defibrillator lead?

2. Why has Medtronic recalled its Sprint Fidelis defibrillator leads?

3. How do I determine if I have a recalled Sprint Fidelis lead?

4. I don't have a Medtronic brand defibrillator.  Am I therefore unaffected by all of this?

5. How many patients have suffered an injury?

6. The Sprint Fidelis lead to my defibrillator has not fractured. What should I do?

7. What is the fracture rate for patients with the recalled Medtronic heart lead?

8. What exactly is the defect with the Medtronic heart lead?

9. What types of injuries have patients with fractured defibrillator leads suffered?

10. Why is Medtronic legally responsible?

11. Has Medtronic agreed to compensate injured persons for their pain and suffering and families of loved ones who died?

12. I was injured.  How quickly must I hire an attorney?

13. What are my legal rights after an injury?

14. Will I have to pay a fee for your review of my case?

15. How long will a lawsuit take?

16. How do I select an attorney to represent me?

17. What recovery will I receive?

18. How will you handle my case?

19. Why don't I just contact Medtronic and work out a settlement with the company?

1. What is a defibrillator lead?

Leads are thin insulated wires connected to a defibrillator that carry electric impulses to the heart in patients with a heart rhythm abnormality.

2. Why has Medtronic recalled its Sprint Fidelis defibrillator leads?

Medtronic actually refuses to call its actions a recall. Instead, on October 15, 2007, Medtronic issued a "voluntary market suspension" to remove its line of Sprint Fidelis defibrillation leads from the market. Medtronic stated that the leads are prone to fracturing which can cause the defibrillator to deliver unnecessary shocks or not operate at all.

3. How do I determine if I have a recalled Sprint Fidelis lead?

Check your patient ID or wallet card. If in any of the rows under the column marked Model #, you see one of the following four sets of numbers, 6949, 6948, 6931, or 6930, then you have the recalled heart lead. These numbers may be shown at the beginning of a longer set of numbers and letters on your ID card.

4. I don't have a Medtronic brand defibrillator.  Am I therefore unaffected by all of this?

No. The Sprint Fidelis leads were connected to defibrillators made by Medtronic as well as other defibrillator manufacturers such as Guidant and St. Jude, and implanted in or sold to an estimated 268,000 patients worldwide since 2004 -- with roughly 235,000 patients still relying on these implanted leads.

5. How many patients have suffered an injury?

In 2007, Medtronic reported that at least five patient deaths associated with fractured Sprint Fidelis leads have occurred and that a small number of patients have had their lead fracture.

However, as listed in an October 16, 2007 letter from Dr. Sidney M. Wolfe of Public Citizen to the Food and Drug Administration (FDA), over 1,600 injury reports have been filed with the agency over the past two years. More than 750 of these reports listed the patient as having received "inappropriate shocks."

For 2008, the FDA database contains over 1,000 reports of patient lead fractures.

6. The Sprint Fidelis lead to my defibrillator has not fractured. What should I do?

The FDA recommends that defibrillator settings be adjusted at the patient's next visit to their doctor. In most cases, the devices can be programmed to give an "early warning" beep when there is a change in the lead impedance (energy going through the lead). While there is no test that accurately predicts when, or if, a lead will fracture, there are often some early clues of lead problems that the physician can detect on interrogation. Some people have been given devices that will allow interrogation of the device over the telephone.

In some instances, a fractured lead is extracted in the best interest of the patient. However, the FDA does not 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 implanting a different lead model and then capping the old lead so it is no longer useable.

7. What is the fracture rate for patients with the recalled Medtronic heart lead?

In 2007, the FDA stated, "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." The number of injury reports filed with the FDA for the Sprint Fidelis lead, however, have increased with time, suggesting the fracture rate is also increasing.

Clinical studies have found a much greater failure rate than reported by the FDA. In a 2006 study of patients at Cornell University Medical Center, 17% of patients experienced abnormal right ventricular sensing, requiring early revision (change out) in 4% of patients. Likewise, a study published in 2004 found the Sprint Fidelis lead functioning in only 88% of patients studied three years after being implanted.

Also relevant is that the recalled Medtronic heart leads, because of their smaller diameter than competing products, were often used in young adults and pediatric heart patients. Medical researches have reported a higher fracture rate with this population. It is believed the leads have come under greater stress in more-active people, including children and young adults.

8. What exactly is the defect with the Medtronic heart lead?

Medtronic has not disclosed the precise reason why its Sprint Fidelis leads are fracturing. In a "Dear Doctor" letter from March 2007 it claimed the technique used by surgeons during implantation may be responsible for the fracturing over time.

In lawsuits filed by heart patients represented by Lieff Cabraser, the plaintiffs allege that the defect is attributable to the small diameter of the coil and conductors in the lead which makes it prone to stress damage both during and after implant surgery. Fracture eventually occurs when the conductor is critically overstressed.

9. What types of injuries have patients with fractured defibrillator leads suffered?

Many patients have experienced terrifying and devastating episodes of repeated electrical shocks due to a fractured lead. In some cases, the patient has died or the lead did not operate properly when the patient experienced abnormal heart rhythms.

10. Why is Medtronic legally responsible?

Manufacturers of medical devices have a duty to patients to produce safe products. In lawsuits against Medtronic prepared by Lieff Cabraser, our clients allege that Medtronic misrepresented the safety of the Sprint Fidelis lead. 

Hundreds of injuries linked to Sprint Fidelis heart defibrillator wires had been reported to the FDA as of the end of 2006. The high and early failure rate of Medtronic Sprint Fidelis leads was also reported in a medical journal in 2006. Yet, Medtronic failed to issue a recall and instead continued to sell the devices.

11. Has Medtronic agreed to compensate injured persons for their pain and suffering and families of loved ones who died?

No. Medtronic has not agreed to compensate patients for their extreme injuries and is denying any legal responsibility. Only by filing a lawsuit or otherwise making a claim against Medtronic can injured patients and families of loved ones who died obtain justice and compensation for their injuries.

12. I was injured.  How quickly must I hire an attorney?

If you or a loved one were just injured, you should not feel pressured to make an immediate decision about hiring counsel. Focusing on restoring your health or mourning the loss of loved ones should take precedence over liability issues at this difficult time.

However, keep in mind that each state imposes a deadline for filing lawsuits. This deadline is known as the statute of limitations, which in certain states is one year from the date of the accident. There might also be other deadlines imposed by state law that may require action sooner than one year.

13. What are my legal rights after an injury?

In most states, an injured person may bring a case for negligence, design defect and other legal claims for compensation. In wrongful death cases, most states provide that the decedent's spouse and children are entitled to sue for damages. If there is no spouse, then a child (or guardian of a child) may sue if there is neither a spouse nor child, then the decedent's parents are entitled to sue. After the parents, siblings are next in line under the law.

14. Will I have to pay a fee for your review of my case?

No. We do not charge to review your case.  If we decide we can represent you and you wish to retain Lieff Cabraser as your attorney, we will discuss our contingent fees (calculated as a percentage of the recovery we obtain) and then provide a written contract to be agreed upon.

15. How long will a lawsuit take?

We cannot give any guarantees as to when your case will be resolved. First we must undertake a thorough investigation of the facts of your case. In some instances, a case will settle to our client's satisfaction shortly after it is filed, or perhaps even before. In other cases, a final resolution may take multiple years.

Rest assured, Lieff Cabraser works swiftly and efficiently to obtain the maximum compensation for our clients and to bring each case to a successful conclusion. We do not charge our clients hourly fees and earn no compensation for ourselves until you receive your recovery.

16. How do I select an attorney to represent me?

You should seek a lawyer who has substantial experience in successfully handling similar cases. It is important to not only verify the reputation and experience of the law firm as a whole, but to be sure that your case will be handled by individuals with appropriate experience. Finally, in suits involving defective medical devices, a case can be expensive to litigate and typically requires the hiring of experts to assist your case. You should choose a law firm with substantial financial resources to conduct the case through trial and appeal if necessary.

17. What recovery will I receive?

In most jurisdictions, if the defendants are found liable, you are entitled to a judgment that fully compensates you for your financial loss. If you suffered a personal injury, the defendant is responsible for paying for your medical care, both past and expected, your past and future lost earnings, and an amount to compensate you for pain and suffering. Your spouse also might be entitled to an award.

If a loved one died, the recovery usually is based on the amount of economic support and services that you lost, plus, in some jurisdictions, an amount designed to compensate for your grief and mental anguish and loss of association. We have economists who specialize in evaluating these injuries and calculating the lump-sum amount to determine a monetary compensation for your loss.

If the conduct that caused the injury was egregious, you may also be entitled to an award of punitive damages in certain states.

18. How will you handle my case?

As our client, you possess the direction and control over the case.  For example, if Medtronic should make an offer to settle the case, we will promptly inform you.  We will advise whether or not you should accept the offer based on the law and facts of your case.  The decision, however, will be yours alone to make.

If you agree to retain our firm, we will prosecute your case as a personal injury lawsuit.  You will be assigned an individual attorney whom will keep you regularly informed as to the status of your case.  At the same time, our attorneys work as a team, sharing evidence and following a strategic plan for the Medtronic heart lead litigation.

19. Why don't I just contact Medtronic and work out a settlement with the company?

It is usually inadvisable to try to resolve a serious injury or wrongful death case on your own. A case may involve multiple parties and questions concerning what happened, who was legally responsible, and how the matter should be resolved. At Lieff Cabraser, not only attorneys but also medical and product safety specialists are trained to evaluate your case and advise you of your rights. Without these experts, you may never know the true value of your case or gather the evidence to show Medtronic's alleged misconduct.

It is important to understand that corporations and their insurers employ the services of expert lawyers who seek to avoid responsibility or at least to minimize the payments that will be made to the victims and families. In contrast, our duty is to identify all responsible parties, maximize the compensation under the law and obtain justice for you.