An estimated 268,000 people were implanted with the Medtronic Sprint Fidelis leads when they received their implantable cardioverter defibrillator device. In October of 2007, there was a Sprint Fidelis lead recall that affects all patients implanted with these devices. The devices are designed to provide the jolt to the heart that can be life-saving when cardiac arrhythmia strikes. To date, there have been at least five people who have lost their lives due to complications with these devices.

Can Removal Avoid a Sprint Fidelis Lead Fracture?

While removing the leads that are the subject of the Sprint Fidelis recall may seem like the obvious solution, it is not that easy. The company itself, in the letter it sent out to customers to announce the recall, said that the risks of removing these devices are higher than the risks posed by the Sprint Fidelis lead fracture problem. Therefore, these patients are essentially stuck with the devices, which may or may not work as intended.

Is there a Medtronic Lead Lawsuit?

There is currently a Medtronic lead lawsuit being heard in federal court. The proceedings were moved to Minneapolis, the home of the Medtronic company, due to the large number of people involved in the case. If you were implanted with any of the devices involved in the Medtronic Sprint Fidelis recall, you are entitled to take part in this lawsuit. You may stand to receive financial compensation for having been implanted with one of these faulty devices.

What Devices Are Affected by the Medtronic Lead Failure Issues?

The Medtronic Sprint Fidelis recall affects four models of leads produced by the company. They include the following medical products:

• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6848
• Sprint Fidelis 6949

If you were implanted with any of these devices, you should contact an attorney to explore your options for a legal remedy to your situation.

What if I Have a Sprint Fidelis Lead Fracture?

If you’re having problems with the Sprint Fidelis lead fracture issues, there may be noticeable physical symptoms. The FDA recommends that you contact your doctor if you’re implanted with one of these devices and if you experience any of the following symptoms:

• Repetitive Shocks
• Lightheadedness
• Dizziness

While these devices are safer left in than removed, according to the company, there is the potential that a Medtronic lead failure will result in a failure of the device to work in the event of a real cardiac emergency. This rather puts those implanted with the devices in a bad situation: leave the faulty device in or risk a surgery to have it removed.

Participating in the Medtronic Sprint Fidelis Lawsuit

The Medtronic Sprint Fidelis lawsuit is open to anyone who is implanted with these devices. If this includes you, contact an attorney to learn more about your legal options and the latest Medtronic lawsuit update news. You may be able to recover financial damages due to having been implanted with these faulty devices.

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 lead recall continue to fight for their rights. The Medtronic recall involves only the Sprint Fidelis leads 6930, 6931, 6948, 6949 and not the implanted heart device.

Hundreds of thousands of people experience heart arrhythmia and require pacemakers to keep their heartbeat steady. The choices between different pacemakers are varied, but you can be certain that they will all have defibrillator lead wires that connect the pacemaker to the heart through the heart valves. These lead wires collect data from the heart and transfer it to the pacemaker, which will then release electric shocks to the heart to keep the heart’s rhythm steady.

Medtronic introduced revolutionary heart leads that had thinner lead wires, which made it easier to implant during the surgical process. Physicians were pleased with the ease with which these lead wires could be inserted, and therefore recommended them to many of their patients. The Food and Drug Administration approved these lead wires for use in 2004, and hundreds of thousands of patients use these Sprint Fidelis lead wires.

Complications with Sprint Fidelis Lead Wires

The thinner lead wires that made implantation easier on physicians are prone to tearing and fracture. When Sprint Fidelis Medtronic lead fracture occurs, the patient can receive unnecessary repeated electrical shocks to the heart, or they may receive no electric stimulus at all. Either condition can lead to serious heart arrhythmia that could result in heart attack and death. Research shows that there have been at least five deaths linked to the Sprint Fidelis leads. Medtronic, Inc., the manufacturer of the Sprint Fidelis pacemaker, estimates that up to 5,000 patients that received the pacemaker with faulty lead wires could experience tearing and fracture within the first thirty months after the implantation of the defibrillator. Patients that have a Sprint Fidelis pacemaker, but have not yet experienced any defects, could still suffer the complications at some point in the future.

Medtronics lawsuit

Many patients that have experienced the complications with Medtronic Sprint Fidelis lead wires are currently involved in a multi-district lawsuit against the medical device company, while hundreds of other patients are seeking legal representation daily. The Sprint Fidelis Medtronics lawsuit is centered in Minnesota, where the headquarters for Medtronic are located.

Claimants are seeking damages for lost wages, medical bills, and emotional distress. The lawsuit claims that the Medtronic Sprint Fidelis was released before adequate testing could be completed. Claimants also believe that the risks of using the Sprint Fidelis were not detailed in the marketing materials. An open letter was sent to doctors after the problems with the lead wires were discovered, but Medtronic continued to manufacture the defective lead wires and distribute them to new patients.

Next Steps for Patients with Sprint Fidelis Leads

It is not recommended to have any lead wires removed if you are not already experiencing problems with the lead wires. The lead wires that are implanted in the heart valves can become embedded in the tissue, which makes removal a very dangerous and complicated surgery. You can, however, have your physician recalibrate your device so that you can receive early warnings for any possible malfunction.

If you have certain models of Medtronic leads connected to your implanted defibrillator device, you may have received a Medtronic recall notice. There are Medtronic Sprint Fidelis lawsuits which has been consolidated through multi-district litigation in Minneapolis, Minnesota. All of this centers on a particular defect that was discovered in certain models of these leads. The Sprint Fidelis lead fracture hazard is very real and, potentially, it can affect the performance of your defibrillator, whether it happens when you’re actively having an arrhythmic event or not.

The Affected Devices

There are four products that are included in the Sprint Fidelis Medtronic lead recall. The following models are affected:

• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949

If you’re implanted with one of these devices, you likely received a notice that you’re affected by the Sprint Fidelis lead recall already. If you’re not sure, you need to contact your doctor to find out whether or not you have one of these devices as part of your defibrillator implant.

The problems with these devices are significant, and center on the tendency of them to fracture, which creates a host of reliability problems.

The Nature of the Medtronic Lead Fracture Problems

The defibrillator device, when working correctly, detects abnormal heart beats and provides an electric shock that puts the heart back into a normal rhythm. The Medtronic lead failure affects the leads that deliver this shock. It can result in a host of potentially unpleasant side effects, and can cause the device to perform unreliably.

A Sprint Fidelis lead fracture can cause the device to deliver shocks to the heart at the wrong times. This may be experienced as a physical sensation of being shocked, as lightheadedness and as dizziness. While this is an issue in and of itself, it can be more hazardous still.

If the Medtronic lead failure affects the intended operation of one of these devices, the consequences may be deadly. Because the device isn’t functioning properly, there’s no way to ensure that issues won’t manifest when the leads are supposed to deliver a life-saving jolt of electricity to the heart. While it may seem that the obvious solution is to have the devices removed to eliminate the possibility of a Sprint Fidelis lead fracture, there are complications involved in this, as well.

The Medtronic Sprint Fidelis Lawsuit

The Medtronic lawsuit 2010 claims regarding this issue is centered in Minneapolis, MN, because the manufacturer’s headquarters are located in Minnesota. There are over 100,000 patients who received the products that are the subject of the Medtronic Sprint Fidelis recall. If you’re one of them, you may be eligible to participate in the lawsuit. The Medtronic lead fracture case is ongoing and may provide recourse for those who have these devices implanted in their bodies and who, therefore, live with the associated risks every day.

In the fall of 2007, following the deaths of five heart patients who had heart defibrillators implanted into their chests, a worldwide recall was initiated that made many other heart patients extremely fearful. Medtronic, the company that produced and distributed the Sprint Fidelis heart leads, faces numerous lawsuits, due to the Medtronic lead recall. There are many questions related to the Sprint Fidelis heart leads, and what the future has in store for the thousands of patients with recalled leads implanted. Please contact us for the latest Medtronic lawsuit 2010 news.

What Went Wrong?

The most obvious question is, what went wrong with the Sprint Fidelis defibrillator leads? Heart defibrillators are self-contained devices that are implanted into the chest cavity of patients who have had a history of cardiac episodes or suffer from heart arrhythmia. The defibrillators work by monitoring the rhythms of a patient’s heart, and when abnormal rhythms are detected, small electric shocks are sent into the heart via the defibrillator lead. This regulates the rhythms of the heart, and prevents any serious cardiac episode from happening.

With the Sprint Fidelis leads, the wires were susceptible to fracturing, meaning that when an irregular or dangerous heart rhythm was detected, the defibrillator was unable to respond with electric shocks. For five patients, this meant full cardiac arrest leading to death.

How Many Heart Patients Were Affected?

The five that died due to the Medtronic Sprint Fidelis lead fracture seem to be the only deaths relating to the problem. However, more than 100,000 heart patients have had the Sprint Fidelis defibrillator leads implanted, and these patients are all over the world.

In the wake of the deaths, Medtronic issued an advisory urging patients that had the Sprint Fidelis heart leads implanted to see their doctor immediately. In most cases, simple tests will be performed to ensure that the leads are in working order. Medtronic, and most health professionals, do not recommend having the Sprint Fidelis leads removed at this time, as that is intensive surgery that can be unnecessarily dangerous.

What Kinds Of Lawsuits Is Medtronic Facing?

Medtronic is facing multiple individual lawsuits following the advisory about their Sprint Fidelis lead recall. Cases are currently pending, having been consolidated through multi-district litigation. Many patients fear the devices that are in their chests are defective, and will not be able to save them.

Patients subject to the Medtronic lead recall currently are faced with no good options. It is not recommended that the potentially defective leads be removed due to the serious nature of explants surgery. However, that then leaves patients with the fear that they could suffer a lead fracture and not receive the life-saving shocks from their defibrillator when needed. Patients continue to file individual claims and there is currently no national Medtronic class action lawsuit.

The Medtronic lead lawsuit claims have been consolidated in multi-district litigation Minneapolis, MN, the headquarters of the medical device company involved. The lawsuit involves Sprint Fidelis lead fracture issues that were discovered through patient complaints, doctors and the company itself. In 2007, Medtronic issued a recall of some models of the leads they manufacture for use with implanted defibrillators. They include the following models and, if your defibrillator is equipped with one of these leads, you may be eligible to take part in the Medtronic lead lawsuit.

Models affected by the Sprint Fidelis Medtronic Lead Fracture issues include:

• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949

What the Sprint Fidelis Lead Fracture Recall Means

An implanted defibrillator is designed to help the heart maintain a regular rhythm. Irregular heartbeats can be fatal and these devices are lifesavers when they work correctly. A Medtronic lead failure prevents these devices from working as intended and, thus, defeats the purpose of the device in some situations.

If your device is affected, the Medtronic lead fracture issues may be manifesting already. The fractures cause the defibrillators to let out pulses when they’re not needed. Some patients will experience this as dizziness and lightheadedness; some will be aware of the device sending a shock. The Sprint Fidelis lead recall, however, involves potentially more significant issues.

The Medtronic lead fracture problems prevent the device from being truly reliable which, obviously, is not acceptable in a life saving device designed to be implanted directly into the body. Unfortunately, removing the device may present even more hazards than just leaving it in, and may have serious implications for the patient. The company itself has admitted that the surgery to remove these devices may not be worth the risk to the patient, leaving patients with few options other than to participate in the Medtronic lead lawsuit.

Who Is Affected by the Medtronic Lead Recall?

There are over 100,000 people known to be implanted with the devices that are the subject of the Sprint Fidelis lead fracture lawsuit. If you have an implanted defibrillator and are concerned that you may have one of the leads that are subject to fracture, you should contact your doctor immediately. Your cardiologist should know which leads you were implanted with. The Sprint Fidelis lead recall does not include other leads manufactured by this company.

The lawsuit is being handled in Minneapolis, but any one of the hundreds of thousands of people affected by the Medtronic lead recall may be eligible to participate in it. The lawsuits are being handled through what is called multidistrict litigation, which allows those affected to participate without being located in the same area where the Medtronic lead lawsuit is being heard.

For many people, an implanted defibrillator is a life-saving device. They allow a patient with an abnormality in their heart rhythm to live a normal life without the constant threat of having a heart attack. However, in October of 2007, there was a Medtronic lead recall that affected literally hundreds of thousands of people. While this is distressing enough, the potential of suffering from a Medtronic lead fracture rather puts those who have one of these leads in a very difficult place.

What They Are

The Medtronic recall affected one of the most vital parts of an implanted defibrillator. When the heart in a patient who has one of these devices takes on an irregular rhythm, the automatic device sends a jolt of electricity into the heart that restores it to a normal beat. These leads need to be reliable, of course, and there is no room for error.

Unfortunately, there was a danger of fracture in these leads that could cause problems. The Sprint Fidelis lead fracture causes the device to send signals at inappropriate times and, potentially, to fail to perform its function when it matters the most. This led to the recall that affected so many patients.

The Consequences of the Sprint Fidelis Lead Recall

Those patients who have these devices installed face a serious dilemma. According to the manufacturer, the patients may face a higher risk from a procedure to remove the device than they do from the device itself. Either way, of course, there is risk, which is why there was a Medtronic lead recall in the first place. This risk was discovered largely due to patient suffering from problems caused by lead failures.

A Medtronic lead failure sometimes results in the patient with the device getting jolts at times where there is no reason for it. This was reported to doctors and the origin of the problem was traced to the Sprint Fidelis lead fracture problems. Sometimes, you may experience these instances as dizziness and lightheadedness. Get to your doctor if you have been experiencing these symptoms.

The Medtronic Lead Lawsuit

Because there were individuals who were affected by the Medtronic lead failure issues all over the nation—there were well over 100,000 patients with leads implanted, in fact—the case was moved to the home city of the company itself, Minneapolis, MN.
You should contact a doctor, and then a lawyer, if you have any of the following products implanted:

• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949

These models are all part of the Medtronic lead recall and are known to be at risk for lead fracture. Contact your doctor immediately if you have one of these implanted and if you weren’t notified about the recall already. Please contact us for the latest Medtronic recall 2010 news.

Heart problems are one of the most serious medical issues for most people as they approach middle age. They are frightening, life changing events that can occur anytime, anywhere without any warning whatsoever. Given the life-threatening nature of cardiac arrests, it is little wonder that patients throughout the United States have been concerned in the wake of five deaths in 2007 due to defective Medtronic heart lead which were part of the Medtronic defibrillator lead recall.

These five people were heart patients, who had previously experienced heart attacks, heart arrhythmia or other cardiac problems and had a small device implanted into their chests. The devices in question were the Sprint Fidelis heart defibrillator, manufactured by Medtronic. The five patients died when the defibrillators were unable to respond to irregular heart rhythms with small electric shocks meant to stabilize the heart due to defective heart leads.

It soon became clear that the reason for the failure for these five patients was due to defective defibrillator leads in the devices. The faulty Medtronic lead failures were caused by defective wiring in the units. In a heart defibrillator, a lead is the group of wires that attach to the exterior muscle tissue of the heart.

From there, they connect to the implanted heart defibrillator located in the chest cavity. Through these leads, the defibrillator monitors the rhythms of a patient’s heart. When an irregular or dangerously abnormal heart rhythm is detected, the defibrillator sends small electric shocks through the lead and into the heart muscle. This then balances the rhythms of the patient’s heart, preventing a cardiac episode or, worse, a full coronary event (heart attack).

What Went Wrong With Medtronic Sprint Fidelis Leads

The Medtronic leads in the five patients who died were found to have been fractured. This could have been due to either a defective manufacturing process, a mistake during implantation surgery, or they could have become fractured after implantation. People have argued that the likely cause was either a defective design or manufacturing process, placing the liability on the manufacturer Medtronic.

The Medtronic Lead Recall

Following the five deaths, and the discovery of Medtronic’s lead fractures, the company issued an advisory and undertook a voluntary recall of all of its Sprint Fidelis heart defibrillators. Even though it was only the leads that were determined to be defective, Medtronic recalled all of their Sprint Fidelis leads, and as of 2010, the Sprint Fidelis defibrillator leads remain implanted in thousands of patients throughout the country.

The Pending Medtronic Recall Lawsuit

In the wake of the five deaths, and the determination that they were likely caused by Sprint Fidelis lead failures, lawsuits began being filed all over the country. Over one hundred thousand patients have had the Sprint Fidelis leads implanted into their chests since they came onto the market. For more information on the status of the Medtronic Sprint Fidelis lawsuit claims please contact us for a free consultation.

On October 15, 2007, Medtronic announced a Sprint Fidelis Medtronic lead recall of its defibrillator leads.   Medtronic announced that the recall was due to “the potential for lead fractures.”   At the time of the recall, there were reports of at least five deaths associated with the defibrillator leads.  The Food and Drug Administration classified the recall as “Class 1,” which is the most serious type of recall and involve situations where there is a reasonable probability that the use of the product will cause serious injury or death. 

What is a Defibrillator?

Some people are at risk of having abnormal heart rhythms. A defibrillator monitors heart rhythms.  If it detects an unstable rhythm, it delivers an electric shock or jolt to the heart (approximately 750 volts, which is more than 100 times the shock delivered by a pacemaker) to shock the heart back to normal rhythm.  A defibrillator contains two parts.  The first is a computerized device that monitors the heart rhythms and decides whether to shock the heart.  This devise is implanted under the skin near the shoulder.  The second part of a defibrillator is called “leads.” These wires are what was covered under the Sprint Fidelis Medtronic recall in 2007. For filing deadlines and the latest Medtronic lead lawsuit news please contact us for a free consultation.

What are Leads? 

Leads are wires that connect to the defibrillator.  They are threaded through veins to specific parts of the heart.  The leads perform two functions: (1) they deliver information of an abnormal heart rhythm to the defibrillator; and (2) send a shock to the heart when an abnormal rhythm is detected.  

Medtronic Lead Fracture Problems? 

Lead fractures, or breaks, can cause the defibrillator to deliver an unnecessary shock to the heart, or fail to deliver a shock when one is needed.  Following a Medtronic lead fracture, some patients have died and many others have reported experiencing problems including unnecessary shocks and jolts.  The following defibrillators have been recalled due to problems with the leads:

• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949

Approximately 268,000 Sprint Fidelis leads were implanted worldwide. 

What do I do if I have a defective Medtronic lead?

There is no way to test for a lead fracture on your own.  If you have a wallet card, check the model numbers for 6930, 6931, 6948, and 6949.  If you have one of these models, or are unsure, the Food and Drug Administration recommends contacting your doctor immediately.  For these models, Medtronic and the FDA recommend patients who have one of the recalled lead models implanted to have their defibrillator settings adjusted, which may increase the likelihood that a fracture will be detected before a patient is harmed.  Medtronic and the FDA recommends against having the leads removed because of removal risks.  However, patients should discuss all options with their physicians.  

Is there a Class Action Lawsuit? 

Lawsuits against Medtronic for defective leads are handled through what is called multidistrict litigation, or “MDL.”  The lawsuits are pursued individually, but are consolidated for the “discovery” phase and transferred to the federal court in Minnesota, which is where Medtronic is located.  After the discovery stage, the cases are transferred back to the original court where they were filed.  This means that, although there could be tens of thousands of cases, they are handled individually.  Many patients have been affected by a lead fracture while others have an implanted lead that was recalled, but have not suffered a lead fracture and continue to be monitored. Please contact us for the latest Medtronic recall 2010 information.