Medtronic Recall Update: Answers to Frequently Asked Questions From Plaintiffs' Attorneys Representing Clients in Defective Medtronic Heart Lead Lawsuits

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Attorneys representing heart patients that filed the first personal injury and class action lawsuits against Medtronic Inc., and related companies, for manufacturing defective defibrillator leads have issued a series of answers to frequently asked questions concerning the Medtronic recall and the legal rights of Medtronic patients.

The Sprint Fidelis leads recalled by Medtronic were connected not only to defibrillators made by Medtronic but also defibrillators made by other manufacturers including Guidant and St. Jude. Patients with the recalled Medtronic defibrillator lead should promptly meet with their physician and discuss their options.

    "It is important for all persons with defibrillators to check their wallet card to see if they received a Medtronic lead," stated attorney Wendy R. Fleishman of the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP. "The Sprint Fidelis leads recalled by Medtronic were connected not only to defibrillators made by Medtronic but also defibrillators made by other manufacturers including Guidant and St. Jude. Patients with the recalled Medtronic defibrillator lead should promptly meet with their physician and discuss their options."

The following questions and answers were posted today on the website operated by Lieff Cabraser:

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 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. Which Sprint Fidelis leads were withdrawn from the market?

The Sprint Fidelis leads that have been recalled contain the model numbers 6949, 6948, 6931 and 6930.

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.

Check your wallet card for your defibrillator and see if anywhere on the card the model numbers 6949, 6948, 6931 and 6930 appear -- either by themselves or at the beginning of a longer number. If these numbers do appear, you most likely received a Medtronic Sprint Fidelis lead.

5. How many patients have suffered an injury?

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."

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 scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed. Unfortunately, no test exists to accurately predict whether a patient's lead will fracture.

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?

The FDA has 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 been escalating with time suggesting the fracture rate is increasing. Moreover, clinical studies have found a much greater failure rate. In a 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.

In addition, the recalled Medtronic heart leads, because of their smaller diameter than competing products, were often used in young adults and child 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 kids, adolescents and younger 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 Medtronic claimed surgeons were responsible for causing the fracturing during implantation of the device.

In lawsuits filed by heart patients represented by plaintiffs' counsel, 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 plaintiffs' counsel, 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 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. 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?

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.

Further Information On Your Legal Rights

Answers to additional questions on the law can be found at:

Contact Information for Plaintiffs' Counsel

If you would like to learn more about the Medtronic recall and your legal rights, please visit:

Patients who have had to undergo surgery to replace a faulty lead or have been advised by a physician their lead may be defective are also welcome to call plaintiffs' counsel toll free at 1-800-948-2181.

About Plaintiffs' Counsel

Representing plaintiffs across America in Medtronic recall lawsuits are Daniel E. Gustafson, Gustafson Gluek PLLC; Elizabeth J. Cabraser, Wendy R. Fleishman, Rebecca Bedwell-Coll, Heather A. Foster, Lieff Cabraser Heimann & Bernstein, LLP; Silvija A. Strikis, Kellogg Huber Hansen Todd Evans & Figel, PLLC; Nicholas J. Drakulich, The Drakulich Firm; Jennings & Drakulich, LLP; Richard J. Arsenault, Neblett Beard & Arsenault; Hunter J. Shkolnik, Rheingold Valet Rheingold Shkolnik & Mccartney LLP; and Seth R. Lesser, Locks Law Firm.

Plaintiffs counsel has been investigating Medtronic's alleged misconduct for months and filed the first personal injury and class actions lawsuits in the nation against Medtronic arising from the recall of Medtronic Sprint Fidelis defibrillator leads.

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