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Medtronic Sprint Fidelis Defibrillator Leads

In October 2007, Medtronic, Inc., recalled approximately 268,000 Sprint Fidelis defibrillator leads (models 6930, 6931, 6948 & 6949) after 655 reported device failures and five deaths associated with fractured leads. Medtronic has been accused of downplaying or even disregarding early evidence the leads could fracture, while continuing to sell the defective leads.

If you have had a Medtronic defibrillator with Sprint Fidelis leads implanted, you may be entitled to personal injury compensation for pain and suffering, lost income and possibly even punitive damages (sometimes awarded to punish a defendant for particularly bad behavior). If your loved one has died, a wrongful death lawyer may be able to help you and your family collect wrongful death damages such as medical and funeral expenses, loss of anticipated future income (including wages, benefits, and inheritances), loss of companionship and, again, punitive damages. You may wish to contact an experienced personal injury attorney to learn more about your rights.

Defective Sprint Fidelis Leads

A defibrillator is a surgically implanted device whose job is to reset abnormally fast heart rhythms and prevent cardiac arrest. The defibrillator is connected to the heart muscle by thin electrical wires, or "leads." If electrodes on the leads detect an abnormal rhythm, the defibrillator shocks the heart through the leads in order to re-establish a normal rhythm. If the leads fracture, the defibrillator may deliver unnecessary shocks or even fail to deliver life-saving shocks to end potentially fatal heart rhythms. As a result, patients may suffer excruciating pain, grave injury or, in some cases, death. To date, there are more than 2,200 reports of serious injuries and 107 deaths associated with fractured Sprint Fidelis leads.

Sprint Fidelis Litigation

You may have heard that recent negligence and strict product liability claims filed in a group action (called a multi-district litigation) were dismissed on grounds of federal preemption. Even so, if you have been injured by Sprint Fidelis leads you may still be able to file a lawsuit. For example, if it can be shown that Medtronic deceived the FDA or failed to manufacture its leads in strict accordance with the premarket approval, there is no federal preemption. Furthermore, Congress is considering the Medical Device Safety Act, which would in effect nullify the recent court ruling. Contact an experienced attorney to learn more about how the laws apply to your case.

Replacing the leads involves a risky surgical procedure — widely considered far more dangerous than replacing the defibrillator itself. Medtronic has attributed at least four fatalities and a high number of reported injuries to surgical procedures that were performed to remove the leads.

While it can be extremely stressful to worry that your life-saving device might fail you, the prospect of a risky surgery can be just as stressful. If you have had a defibrillator implanted with Sprint Fidelis leads, an attorney specializing in product liability cases can tell you more about the possibility of obtaining compensation for mental anguish, physical pain and other problems this product may have caused you.

Liability for Defective Sprint Fidelis Leads

If a person is injured because of an unreasonably dangerous medical device, anyone in the supply chain (such as manufacturers, wholesalers and retailers) could be legally responsible under product liability law. Defective medical device cases are usually based on one or more of the following claims:

  • The design of the device made it unreasonably unsafe
  • The product was defective because of an error in the manufacturing process
  • The labels or warnings failed to provide appropriate warnings of possible dangers and/or instructions for safe use

Depending on state law, legal theories such as strict liability (meaning you need only demonstrate the product was defective and caused harm), negligence and failure to warn may apply.

Lead Integrity Alert Software

A significant number of patients have not had their leads removed because of the serious risk associated with the surgery. Accordingly, Medtronic developed Lead Integrity Alert Software to help protect patients who still have their Sprint Fidelis leads implanted. This software is designed to:

  • Warn of lead fracture - this software directs the device to listen for signals that indicate the lead has fractured and make a special sound if it senses a problem.
  • Decrease inappropriate shocks - the software also can increase the amount of time the device spends looking for problems like a lead fracture or an irregular rhythm to reduce the risk of unnecessary shocks.

Unfortunately, the software does not decrease the risk of device failure. You may wish to consult your physician to learn more about this program.

In recent years, the laws governing pacemakers, defibrillator leads and other Class III medical devices (the most stringent regulatory category requiring FDA pre-market approval) have been in a state of change. Device manufacturers claim that almost all product liability actions for injuries caused by FDA-approved medical devices are preempted by federal law. Patients argue that the protections state laws afford are legal and necessary. You may wish to speak with a product liability attorney who will know the status of the law and how it may affect you.

Filing a Product Liability Lawsuit

Components of life-saving medical technology (like the Sprint Fidelis leads) are supposed to function properly to safeguard the patient's existing health. Unfortunately, in the case of Sprint Fidelis leads, it has proved quite the opposite. If you are considering filing a legal claim for injuries related to Sprint Fidelis leads, a products liability attorney can help you determine your legal rights. You should be aware that there are statutes of limitations that impose time limits on the filing of your claim. If you fail to adhere to these time limits you risk losing your legal rights forever.

[Last revision: July 12, 2010]



Did You Know?

A new study suggests that three years after implantation, Sprint Fidelis leads were only functioning in 88 percent of the patients (in contrast to Medtronic's claim of 95 percent).

Source: Heart Rhythm