Sprint Fidelis Leads

Internal cardioverter defibrillators are used to monitor and regulate the heartbeat of patients who suffer from sudden and life-threatening arrhythmias. The defibrillators are implanted in the patient, and the leads channel from the device to the heart. These leads help the device communicate with the heart, and also provide the pathway to deliver an electric jolt if needed, to return the heart to a regular rhythm.

The Sprint Fidelis leads are narrower than previous models, which made them easier to implant. However, patients began experiencing lead problems when the wires began to spontaneously break. When a Medtronic lead fracture occurred, the heart could not accurately communicate with the defibrillator. In some cases, this means that the defibrillator would mistakenly receive a message that the heart was beating irregularly, and therefore the defibrillator would send a jolt of electricity to the heart. In other cases, a heart might be beating abnormally, but the leads would not transmit that message, thereby creating a life-threatening condition.

Medtronic Lead Recall

Unlike a food or pharmaceutical recall, a patient with a questionable Sprint Fidelis lead cannot just discontinue using the product. Because it is intertwined with the heart, it can be tricky to remove the leads. In fact, of the 13 known fatalities attributed to the use of Sprint Fidelis leads, four of them occurred as a result of the process of removing the leads.

While Medtronic did recall the Sprint Fidelis leads, they acknowledge that patients with asymptomatic leads should leave them in place. Those patients are in limbo while they wonder if their device is working, or while they fear an unneeded “kick in the chest.”

Patients who need to have their recalled leads removed are advised to seek a surgeon experienced in lead removal at a medical facility that frequently performs this process.

Patients Frustration Results in Medtronic Lawsuits

Many of the 125,000 people who still have the recalled leads implanted are frustrated. They claim that the Sprint Fidelis leads had problems soon after it hit the market. They believe that Medtronic was aware of these problems, but did not choose to recall the product for years. As a result, patients are filing lawsuits seeking compensation for the injuries, psychological distress and financial expenses they have endured.

If you have a defibrillator with recalled Sprint Fidelis leads, we invite you to contact us for a free consultation to discuss your legal options including filing a Medtronic lead lawsuit. As always, there are never any fees unless we win compensation for your case.

The defibrillator is a device that is inserted into the chest and helps regulate the heartbeat. Wires that connect the device to the heart are called leads, and one particular set of leads, under the name of Sprint Fidelis, are more likely to fracture or break. As a result, a person with a fractured lead may receive electric jolts intended to regulate the heart when not needed. Conversely, the device may fail to deliver jolts when needed.

Although Medtronic has notified over 150,000 people in the U.S. who have received this device, this Medtronic lead recall is a difficult one. Often when a product is recalled, such as a food, consumer product or a medicine, the user can simply stop taking it or use an alternate brand. Or, say in the case of an automobile recall, the manufacturer can repair the problem and return the car to the owner.

It’s not so simple in the case of Medtronic. Because the device is implanted, it becomes more difficult and dangerous to operate to replace the leads. Tissue in the body often covers the leads, making them difficult to extract. In some cases, it may be riskier to replace the leads than to leave functioning ones in place. Of the 13 deaths associated with Sprint Fidelis leads, at least four were the result of lead extraction.

So what should a person with a Sprint Fidelis lead do? First, consult with your doctor. He or she can advise you, based on your individual health and heart condition, on your best course of action. If you decide to have the leads extracted, it is important to find a doctor who is experienced in this type of surgery.

If you choose to allow the Sprint Fidelis leads to remain in place, you should know the warning signs of possible fracture. If the device detects an irregular heartbeat, it is designed to give the heart an electric jolt. If your device begins to deliver frequent jolts, see your doctor. Your doctor can run a report from the device to determine if there was an irregular heartbeat at the time of the shock. If so, the device was working appropriately. If not, you may have a malfunction in the device or the lead.

On the other hand, if you are experiencing physical symptoms such as weakness, dizziness, fatigue, or irregular heartbeat and you have NOT been receiving an electric jolt, you should see your doctor to ensure that your ICD is working properly and that there are no other health problems.

Either decision you make will be a difficult one. And although we cannot make that decision for you, we offer free consulting for patients who are navigating this dilemma. We represent all Medtronic lead fracture clients on a contingency basis, which means there are never any legal fees unless we win compensation in your case. For a free-no-obligation consultation, please call toll free or e-mail us to talk with a Medtronic recall lawyer.

The defibrillator, which is designed to regulate an irregular heartbeat caused by conditions such as ventricular tachycardia or ventricular fibrillation, monitors the heart beat and delivers a jolt of electricity if it detects an abnormal rhythm or rate. When the lead breaks, however, the defibrillator can deliver a jolt even when the heartbeat is normal. It can also fail to deliver a jolt when the heartbeat is abnormal.

Nearly a quarter million people in the U.S. currently have defibrillators with Sprint Fidelis leads. While Medtronic says that only 3-6% of the leads malfunction, other studies indicate that a much higher percentage will malfunction in the next four years.

While it is possible to replace the leads, the lead removal procedure is complicated and potentially risky. Tissue sometimes covers the leads making them difficult to extract. Doctors agree that it may be safer to leave functioning leads in place.

Still, for patients who have a Medtronic lead fracture, replacement is usually recommended, unless the patient is extremely fragile, and the surgery and recovery would take away a significant amount of the patient’s expected lifespan.

If you and your doctor do want to have your leads removed, it is essential to find experienced surgeons to handle the procedure. Of the 13 people who died as a result of the Sprint Fidelis leads, four deaths are a consequence of lead extraction.

The Heart Rhythm Society, an organization of arrhythmia experts, says that there are currently too few doctors with the experience necessary to do the lead extraction procedure. This is will no doubt become of greater concern if there is indeed an increase in malfunction of the leads.

For now, the Heart Rhythm Society says, patients seeking extractions should look for medical centers that have trained doctors to complete many successful extractions. Doctors should perform at least 40 extractions under supervision before doing the surgery independently. A supervising doctor should complete 75 extractions with a high rate of success.

The Heart Rhythm Society also recommends that a national database be established that would have success and failure rates of hospitals conducting this surgery, as a way of helping physicians establish better protocol for success.

In the meantime, patients can ask their medical center its success and failure rate.

If you have a Sprint Fidelis lead, please contact us. We represent all Medtronic fracture 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 or fill out our short online contact form and a Medtronic recall attorney will contact you to answer any of your questions regarding the ongoing litigation and filing deadlines for a Medtronic lawsuit.

Getting an Implanted Defibrillator

You’ve just received the news: that breathlessness, fatigue and chest pain you’ve been experiencing? Your heart is not pumping blood to your body efficiently. The doctor says you need a defibrillator to regulate your heartbeat, which will create stronger pumping.

Understanding more about what a defibrillator is and how it is used may help ease worries and get you prepared for the procedure.

What is an Implanted Cardioverter Defibrillator (ICD)?

When the natural electrical impulses in the heart do not perform correctly, your heart can beat too quickly or irregularly, leading to serious medical problems. People with a history of heart disease may be at risk for tachycardia, in which the heart beats too quickly, or fibrillation, in which the heart beats both too quickly and erratically. Because of the rapidity of heartbeats, the heart cannot deliver blood throughout the body. In mild cases, it can lead to dizziness, faintness or chest pain. In extreme cases, it can result in cardiac arrest and sudden death.

An ICD is a very small computer that monitors the heart rate and delivers electrical shock to your heart in order to re-establish an appropriate rhythm and frequency. The Medtronic Sprint Fidelis leads were implanted in over 150,000 patients prior to the Medtronic lead recall in 2007.

Powered by a long lasting battery, a defibrillator is about the size of an iPod Nano, and is inserted in the chest near the collarbone. Wires or leads from the device are connected to the heart. During your doctor’s visits, the defibrillator can transmit information to your doctor’s computer so he or she can assess your heart’s function and program the ICD.

The Procedure

Your doctor will walk you through specific steps, however, you can expect an overnight stay in the hospital after the procedure is complete. You should bring all prescription and over the counter medicines as well as any vitamins or supplements to your doctor in case any of them affect the medicines you will be receiving during the procedure. You will be given a local anesthetic to numb the area, and perhaps medication through an IV to help you relax. Doctors will monitor your heart using an electrocardiogram (EKG).

When it is time to implant the ICD, the doctor will make a small incision in the chest and will guide the leads to the heart via a vein. The leads will not be visible once the procedure is completed.

Once the leads are in place, they are connected to the ICD and tested. The doctor will then insert the device under the skin and close the incision.

You may feel soreness at the site, and your doctor may recommend you temporarily restrict movement in your shoulder area. Your doctor will advise you on when and how to resume your normal activities.

It will be extremely important to maintain follow up medical care. This will help your doctor gauge the effectiveness of the ICD and make any changes to its programming. Be sure to tell your doctor of any concerns or changes you experience with your ICD. Some ICDs have had trouble with their leads breaking, causing too few or too many electrical shocks, so be sure to let your doctor know if you are receiving shocks that seem unnecessary, or if you are feeling symptoms without receiving a resulting shock.

The defective Sprint Fidelis leads manufactured by Medtronic have been recalled, but people who may already have them implanted need to determine how to resolve this medical concern.

If you have a Sprint Fidelis lead, please contact us. We represent all Medtronics 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 or fill out our short online contact form and a Medtronic lawsuit attorney will contact you to answer any of your questions regarding the ongoing litigation.

Medtronics Sprint Fidelis Recall for Heart Defibrillator Leads

If you are one of a quarter of a million people using a Medtronic defibrillator, you may be at risk for a malfunction in the defibrillator leads.

Medtronic’s defibrillator contains a type of wire with the brand name of Sprint Fidelis. These wires (also called leads) attach the defibrillator to the heart in order to monitor the heartbeat and to provide an electrical jolt as necessary to regulate the heart beat.

In some patients, the Sprint Fidelis wires have broken, or fractured. As a result, the defibrillator may send a massive electrical jolt to the heart. Conversely, it may not give a jolt of electricity when necessary.

The Sprint Fidelis lead was first used with an implantable cardioverter defibrillator (ICD) in 2004, with the advantage of the lead being thinner than its predecessor. However, that thinness may make the lead more susceptible to breakage.

In 2007, after the deaths of five patients using this device, Medtronic recalled this product. To date, a total of 13 patients have died in association with the use of Sprint Fidelis leads.

Nevertheless, in 2009, estimates are that 150,000 patients still have the leads implanted. It has been reported that lead failed in 5% of the devices after 45 months of use, which means at least 7,500 people may be at risk.

Unfortunately, there is no definitive way to determine which leads may fracture and which may not. In addition, the process of removing the leads is risky. After the defibrillator has been implanted, the leads may become covered with tissue, which makes them difficult to extract. Surgeons must be extremely careful not to puncture the heart or surrounding veins, which could cause excessive bleeding. At least four of the 13 deaths associated with Sprint Fidelis were due to lead extraction.

Medtronic, the largest maker of electronic heart devices, recommends that patients with a Sprint Fidelis defibrillator see their doctor to determine the best course of action, and suggests that in some cases, it may be safer to let the leads remain in place.

Medtronic has said it will pay for the cost of replacing defective leads, however this is only for patients whose defibrillator leads have actually fractured. Extraction surgery is a complicated and expensive procedure.

Experts recommend that anyone considering having the Spring Fidelis leads replaced find a hospital with solid experience in removal of the leads. Patients should look for medical facilities that have successfully completed at least 50 removals.

If you are a patient with a Sprint Fidelis lead, we encourage you to call us for the latest status of filing a Medtronic lawsuit.

We represent all Sprint Fidelis lead fracture 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 or fill out our short online contact form and a Medtronic recall attorney will contact you to answer any of your questions regarding the ongoing litigation.