Medtronic Lead Lawsuit 2010

Some people who have been harmed by defective Medtronic leads have filed lawsuits against the manufacturer. But, before filing a Medtronic lead lawsuit, there are several things that you should know.

Which product is defective?
Medtronic Sprint Fidelis defibrillator leads were more prone to fracturing than previous generation models of leads. Defibrillators are implanted heart devices that shock abnormal heart rhythms back to a normal rhythm. Leads are wires connecting the defibrillator to the heart.

What is being done about the defective Medtronic leads?
Medtronic suspended distribution of these defibrillator leads in 2007. Suspending the distribution of the defibrillator leads is classified as a “recall.” However, this does not mean that the leads should be taken out of patients. The FDA stated in a news release that: “We recognize that some patients and health care professionals might inappropriately interpret the word ‘recall’ to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.” More than 268,000 Medtronic Sprint Fidelis leads have been implanted worldwide, according to the manufacturer. There have been multiple patients whose deaths may have been related to defective Medtronic leads. Some of these deaths led to a Medtronic lead lawsuit.

The Medtronic lead lawsuits were filed in courts all over the United States. Eventually, all of the Medtronic lawsuits in federal court were coordinated for the discovery phase and pretrial purposes before U.S. District Court Judge Richard K. Kyle of the District Court of Minnesota.

On January 5, 2009, Judge Kyle found that under the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, the Food and Drug Administration has exclusive authority to make all decisions as to the safety and effectiveness of medical devices. Judge Kyle concluded that Medtronic is shielded from having to account for severe injuries suffered by patients who received its Sprint Fidelis heart leads.

Then, in May 2009, Judge Kyle dismissed more than 200 of the Sprint Fidelis cases pending before him. He found that all claims having to do with the Sprint Fidelis devices are preempted and that no individual can bring a private lawsuit against Medtronic and its subsidiaries. In his opinion, Judge Kyle wrote, “… the court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the court is not unsympathetic to their plight. But plaintiffs assert claims for which the court simply cannot provide a remedy…” The cases were appealed, and a decision should be released soon.

If you have been injured by a defective Medtronic lead, please contact an experienced Medtronic lead fracture attorney as soon as possible.

Medtronic Lead Fracture News

Medtronic manufactured a type of heart defibrillator lead that had defective wires. The defective wires were “leads,” which connected the defibrillator to the heart. The leads would fracture, or break, on numerous defibrillators. The Medtronic lead fracture was deadly in some patients.

Which defibrillators were defective?
The Medtronic lead fracture would occur in the Medtronic Sprint Fidelis leads. More than 268,000 Medtronic Sprint Fidelis leads have been implanted worldwide, according to the manufacturer.

Are these defective leads still being produced?
Medtronic suspended distribution of the defective defibrillator leads in 2007.
Suspending the distribution of the defibrillator leads is classified as a “recall.” However, this does not mean that the leads should be taken out of patients. The FDA stated in a news release that: “We recognize that some patients and health care professionals might inappropriately interpret the word ‘recall’ to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.” There is no test to predict which leads will fracture.

What can I do if I have a defective Medtronic defibrillator?
Patients with Medtronic Sprint Fidelis defibrillator leads should first consult with their doctor. If you have a defibrillator and do not know the manufacturer and model of the lead, you should quickly contact your doctor. A small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic.

The FDA agrees with Medtronic 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 fractured lead will be detected before a patient is harmed, according to the FDA. Doctors should “weigh the risks and benefits of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model,” according to the FDA.

Can I sue Medtronic?
If a Medtronic lead failure has caused you or a loved one harm, then you may be able to file a lawsuit against Medtronic. You should immediately contact an experienced attorney to discuss this. Cases are being pursued individually, but some parts have been combined into what is called Multi District Litigation, or MDL. The MDL handles issues that are common in every lawsuit, such as discovery matters. The cases are then returned to the original court in which they were filed after the completion of the discovery stage of the Medtronic lead lawsuit.

Medtronics Lawsuits News

Medtronic has been has been involved in litigation for defective Sprint Fidelis heart defibrillator leads. These Medtronics lawsuits were initiated because the “leads,” which are wires that connect the defibrillator device to the heart, could break, causing serious injury, and even death in some patients.

How many defective leads were produced?
More than 268,000 Medtronic Sprint Fidelis leads have been implanted worldwide, according to the manufacturer. There have been multiple patients whose deaths may have been related to defective Medtronic leads. Some of these deaths have led to Medtronic lawsuits brought by persons harmed.

Are the Sprint Fidelis leads still on the market?
The Sprint Fidelis leads are not still on the market. Medtronic suspended distribution of these defibrillator leads in 2007. Suspending the distribution of the defibrillator leads is classified as a “recall.” However, this does not mean that the leads should be taken out of patients. The FDA stated in a news release that: “We recognize that some patients and health care professionals might inappropriately interpret the word ‘recall’ to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.”

What can your doctor do about the defective leads?
Patients with a Medtronic Sprint Fidelis defibrillator leads should schedule a consultation with their doctor. If you have a defibrillator and do not know the manufacturer and model of the lead, you should quickly contact your doctor. A small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic.

The FDA agrees with Medtronic 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 fractured lead will be detected before a patient is harmed, according to the FDA. Doctors should “weigh the risks and benefits of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model,” according to the FDA.

What can a lawyer do about harm caused by defective leads?
If you or a loved one has been harmed by a defective Sprint Fidelis heart defibrillator lead, you should contact an experienced attorney as soon as possible. Cases are being pursued individually, but some parts have been combined into what is called Multi District Litigation, or MDL. The MDL handles issues that are common in all Medtronic lawsuits, such as discovery matters. The cases are then returned to the original court in which they were filed after the completion of the discovery stage of the Medtronic lawsuits. There are time limits to filing a claim, however, so you should contact an experienced Medtronic lead recall attorney right away if you have been harmed.

Medtronic Lawsuit Dismissed 2010

If you are seeking Medtronic lawsuit dismissed 2010 information and news about the recall related to your internal cardioverter defibrillator, we can provide the necessary background, facts and resources you need.

Medtronic Defibrillator

Medtronic is a manufacturer of a variety of medical products, notably of the Medtronic defibrillator. The internal cardioverter defibrillator is a small computer that is used to monitor and regulate heartbeats, especially in people who have life-threatening arrhythmias. If the defibrillator senses an abnormal heartbeat, it will send a jolt of electricity to the heart to shock it back into a regular rhythm.

The defibrillator is inserted into the patient, possibly in the shoulder area or chest, but sometimes in the abdominal area. Since it is about the size of an iPod, it can be placed under the skin with minimal detection.

Sprint Fidelis Leads

The defibrillator contains leads, or wires, which are connected to the heart through a vein. These leads are the subject of the recent recall. Some Sprint Fidelis leads that were used in Medtronic defibrillators between 2004 and 2007 fractured, or broke.

When the leads break, it disrupts effective communication between the defibrillator and the heart. The defibrillator may not recognize an irregular rhythm. Or, instead, it may believe a normal rhythm is abnormal, and deliver an unnecessary jolt of electricity.

Who is Affected?

Over 250,000 people have used the Medtronic defibrillator with the Sprint Fidelis wires. After five people died after the Sprint Fidelis wires fractured, a Medtronic recall of the Sprint Fidelis leads models 6930, 6931, 6948 and 6949 was announced. Although the leads are no longer used, more than 100,000 people still have these recalled leads implanted.

Medtronic recommends that patients who are not having any problems with their recalled leads leave them in place and monitor them, with the help of their physician. Removal of the leads can be tricky because the wires can become intertwined with heart tissue, making them difficult to extract safely.
In fact, patients who need to have the wires removed face significant risk during this process. Of the 13 patients who have died as a result of the broken leads, at least 4 deaths were caused by lead removal.

Medtronic Lawsuits

Numerous patients with the Sprint Fidelis leads are suing the company, claiming that Medtronic had received reports of lead breakage at least three years before the recall was announced. Patients seek financial compensation to assist with medical costs as well as with emotional and physical trauma.

If you have a Medtronic defibrillator lead with the recalled Sprint Fidelis wires, and you are considering filing a Medtronic lead lawsuit, we encourage you to contact us for a free consultation to discuss your legal options.

Medtronic Sprint Fidelis Lawsuit

Patients across the country continue to file Medtronic Sprint Fidelis lawsuit claims spurred by lead recall of the Sprint Fidelis wires. As patients face long-term side effects from the faulty defibrillator wires, they seek compensation from the company they believe knew of the wire problems long before the recall was issued.

A defibrillator is a life-saving device that is implanted in patients who have an abnormal heartbeat. If the heart beats too quickly or too irregularly, not enough blood can fill up the chambers of the heart, to be distributed through the body. Blood may pool in the chambers and develop into clots that can lead to a stroke. The heart may also begin to quiver ineffectively, leading to sudden cardiac arrest.

When a patient exhibits signs of an irregular heartbeat, such as an arrhythmia or tachycardia, doctors may determine he or she needs the small computer-like defibrillator to monitor the heartbeat and provide a jolt of electricity as necessary to regulate it.

The defibrillator, which is about the size of an MP3 player, connects to the heart by several wires, which are called leads.

Medtronic, which produces numerous medical devices, began to use narrow leads in its defibrillators, believing that the narrower leads were an improvement because they were easier to insert than the previous ones.

Unfortunately, these Sprint Fidelis leads were also more likely to fracture or break. Initially, Medtronic officials believed the reports of breakage were due to surgeon error, but eventually they realized the fault was with the leads themselves.

When the leads broke, they no longer reliably transmitted information from the heart to the defibrillator. This meant that the defibrillator was not always able to monitor the heartbeat accurately. In some cases, the defibrillator might not recognize an abnormal heart rhythm or send a life-saving jolt of electricity. In other cases, the defibrillator might detect an abnormal heart rate where there actually wasn’t one, and shock the patient unnecessarily.

Finally, three years after the Sprint Fidelis lead were introduced to the market, they were recalled. However, in that interim, many people had received the defibrillator and the faulty leads.

Many of the Medtronic lawsuits claim the Medtronic lead recall did not occur as soon as it should. Patients claim that reports about problems with a Medtronic lead fracture began to surface soon after Sprint Fidelis went to market, however the leads continued to be used.

Patients who currently have the faulty Sprint Fidelis leads often live in limbo. Since the removal of the leads is risky, patients are advised to watch and wait unless the leads are obviously fractured.

If you are considering a Medtronic lawsuit because of the lead recall, you may have questions about the process. We offer a free consultation where we can discuss your individual situation and determine your legal options. As always, there is no charge unless we win compensation for your case.

Medtronics Lawsuit 2010

The Sprint Fidelis Medtronics lawsuit is designed to help patients and their families who have been affected by a malfunctioning wires that connects to a heart defibrillator.

A defibrillator gives an electric shock to the heart when the heart is not beating normally. The shock jolts the heart back into a regular rhythm. In emergency rooms or on television shows, you may see an external defibrillator, with the pads that are applied to the patient’s chest, as the doctor orders “clear.”

When the Medtronic defibrillator is at work, it isn’t nearly that dramatic. This defibrillator is used internally, so it is implanted in the patient’s chest or shoulder area, and is quite small. This small computer monitors the patient’s heartbeat and if it senses an irregularity, it provides a shock to re-establish the correct rhythm.

The defibrillator connects to the heart via leads, or wires. Between 2003 and 2007, Medtronic used a certain lead with the brand name of Sprint Fidelis with its defibrillators. These Sprint Fidelis leads were believed to be better than previous wires because they were thinner, and therefore were easier to insert into the patient’s veins.

Unfortunately, the thinner Sprint Fidelis leads were also more prone to breaking. When a Medtronic lead fracture occurred, the information that they transmitted from the heart to the defibrillator was sometimes faulty. The defibrillator might not get the message that a heartbeat was irregular, and therefore might not deliver a life-saving burst of electricity. Or, the defibrillator might get the message that the heart was beating irregularly, even if it wasn’t, and deliver a shock unnecessarily.

After the deaths of five patients, a Medtronic recall of the Sprint Fidelis leads was announced, but hundreds of thousands of heart patients are still affected. The process of removing and replacing the Sprint Fidelis leads is complicated. Once the leads have been implanted, they often become covered with tissue in the heart, and it is difficult to extricate the wires. In fact, of the 13 deaths associated with Sprint Fidelis leads, four of them were related to the lead removal process.

The Medtronic Sprint Fidelis lead lawsuit arose when patients claimed that Medtronic was aware of problems with the leads long before the recall was issued. Reports indicate that just months after Sprint Fidelis entered the market with these leads in 2003, the company was aware of concerns about breakage. Yet the leads continued to be implanted. At one time, at least a quarter of a million people had Sprint Fidelis leads as part of their Medtronic defibrillators.

We believe that companies like Medtronic should be held accountable when their products injure people. If you have been affected by the Sprint Fidelis recall, we invite you to contact us for a free consultation to discuss your legal options including being part of a Medtronic lead lawsuit. There is no fee unless we win compensation for your case.

Medtronic 6949 Lead Recall

The Medtronic 6949 lead recall of Sprint Fidelis heart leads has caused great concern and frustration for patients who use the device and affected wire.

Medtronic, a manufacturer of medical devices, makes an internal cardioverter defibrillator, which monitors and regulates the heartbeat of patients who have life-threatening heart irregularities. From 2003 to 2007, the defibrillator used heart leads, or wires under the brand name of Sprint Fidelis.

The Sprint Fidelis leads connect the defibrillator, which is inserted into the chest or shoulder area, with the heart. The leads transmit information to the defibrillator and if the heartbeat becomes irregular, the defibrillator can deliver a jolt of electricity that travels through the leads to the heart to help re-establish a regular rhythm.

For the Medtronic heart leads, the problems began when the Sprint Fidelis leads began to break or fracture. When a Medtronic lead fracture occurs, the communication between the defibrillator and the heart becomes unstable. As a result, the leads may not transmit information from the heart accurately. The defibrillator may not receive the message that the heartbeat is irregular, and therefore may not send the electric shock needed to stabilize the heartbeat. On the other hand, the defibrillator may receive a false message that the heartbeat is irregular, and deliver an unneeded dose of electric shock.

Although Medtronic issued a recall of the heart leads in 2007, patients are still coping with the problem. Once the leads are inserted into the veins leading to the heart, they often become intertwined with tissue, making removal complicated. In fact, of the 13 deaths related to the Sprint Fidelis leads, four of them were associated with the removal process.

Because of that, Medtronic suggests that patients leave the leads in place unless there is an obvious breakage. With the cost of lead removal prohibitive, and the procedure risky, patients and their doctors must monitor the devices and wait in limbo. Still, some patients report receiving unnecessary shocks from the device, which can cause patients physical and emotional trauma over time.

What is particularly frustrating to patients is that the makers of Sprint Fidelis may have known about problems with the heart leads years before the recall was issued. Reports indicate that shortly after the leads entered the market, breakage issues emerged. However, the leads continued to be used in patients. At one point, the manufacturer indicated that the problem stemmed from surgeon error. However, after the deaths of five people who had Medtronic lead fractures, the company decided on a recall.

If you or someone you love is affected by the Medtronic recall of heart leads, you may have questions about your legal rights. We can help. We offer a no-obligation, free consultation to discuss your particular situation and help determine if you are eligible for compensation and filing deadlines for a Medtronic lead lawsuit.

Medtronic Recall Lawsuit News

An implanted cardioverter defibrillator (ICD) is a device used to regulate the heartbeat of patients with life threatening heart conditions. Implanted in the chest, with wires that connect to the heart, the ICD monitors the heartbeat to make sure it is not too fast or too erratic. If that does happen, the ICD provides an electric shock that helps the heart return to a normal rhythm. If you or a family member has a recalled Sprint Fidelis lead please contact us for the latest Medtronic recall lawsuit news. We are currently continuing to file lawsuits on behalf of patients affected by the Medtronic lead recall.

While medical professionals are confident that the ICD can help prevent sudden cardiac arrest and extend the life of patients prone to irregular heartbeats, living with a defibrillator still requires some adjustments.

Immediately after the implantation, patients will feel some soreness at the insertion site, and the doctor may suggest temporary limited movement on that side.

Patients should be aware of other restrictions and cautions:

Driving: Patients receiving the ICD because of a ventricular arrhythmia are advised not to drive during their first six months with the device. If someone is behind the wheel when suffering an arrhythmia or the resulting electrical shock, they could lose consciousness and control of their vehicle. If after six months, no shocks have occurred, patients may begin driving with their doctor’s approval.

People who received the implantation as a preventative measure may be allowed to drive a week after the procedure.

Electro/Magnet Interference: Patients with ICDs must use caution around certain devices. People with ICDs should not use power tools such as chain saws or welding tools. Energy from these tools can interfere with the defibrillator, causing the defibrillator to deliver an unnecessary electrical shock.

Patients should be careful when passing through airport security systems or being close to power generators because of signal interference.

Normal use of a cell phone or microwave should not interfere with the function of the ICD.

Continued Medical Care and Defibrillator Maintenance: ICD patients will still need to continue their medical care. They will have follow up visits with their doctor to monitor the ICD. Eventually, the battery in the ICD will need to be replaced. Sometimes, the ICD or one of its parts will need to be repaired or replaced.

Talk with your doctor if you have a Medtronic defibrillator using Sprint Fidelis wires or leads. Research has shown that these leads have a higher rate of fracture or breakage. The leads may not be able to monitor the heartbeat effectively and may give shocks unnecessarily, or may not give them when needed.

Medtronic Recall Lawsuit

If you are a defibrillator patient with Sprint Fidelis leads, we invite you to contact us to discuss your legal options. We represent all Medtronic 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 lead recall attorney will contact you to answer any of your questions regarding the ongoing litigation.

Medtronic Lead Fracture | Sprint Fidelis Settlement

Living with a heart condition? You are not alone. Heart disease is prevalent in the United States, and is the leading cause of death in this country. If you have suffered from a Medtronic lead fracture please contact us for the latest news on a potential Sprint Fidelis settlement and ongoing litigation updates. According to the Centers for Disease Control and Prevention, 90% of the people who have heart disease have one or more of the following risk factors:

• High cholesterol
• High blood pressure
• Diabetes
• Cigarette smoking
• Overweight and obesity
• Poor diet
• Physical inactivity
• Alcohol use

Heart disease can take many forms and can result in heart failure, heart attack, and irregular heartbeats. When heart disease occurs, the heart cannot pump blood effectively through the body. Whether it is because of narrowing of arteries due to the buildup of cholesterol, or malfunctions of the heart valves, such as ventricular tachycardia or ventricular fibrillation, it is essential to work closely with your doctor to help slow, stop or reverse the disease.

In some cases, the prescription for better health may be to stop smoking, lose weight and increase exercise. In other cases, you may need to take a temporary or long-term medicine to help regulate your condition, such as blood pressure medicine or insulin for diabetes.

Still in other cases, you may need surgery to remove a blockage. In situations where the heartbeat is irregular and creates a life-threatening situation, you may need to get a device implanted in the chest to control the heartbeat.

This device, called an implantable cardioverter device, or ICD, delivers a small jolt of electricity when it detects an irregular heartbeat. This jolt stimulates the heart and helps re-establish a normal rhythm.

Unfortunately, even the ICD is not always the ultimate solution to an irregular heartbeat. In fact, it can sometimes present additional problems of its own. The Medtronic ICD using Sprint Fidelis wires is an example. When it was introduced in 2004, it was believed to be a superior device because the wires that connected the device to the heart were narrower than previous models, making them easier to insert.

However, those wires have also shown to be more fragile and more likely to fracture. Patients with a Medtronic lead failure of the wires may get unnecessary jolts of electric shock. The device may also fail to give a shock when needed.

Nearly 125,000 people are still affected by these wires which were part of the Medtronic lead recall, which are difficult and dangerous to replace.

Heart disease can provide numerous challenges. By doing all you can to maintain a healthy lifestyle and limit your risk factors, along with closely following your doctor’s recommendations, you help decrease your chances of further complications.

Please contact us if you or a family member has suffered from a Medtronic lead fracture and for the latest news on a potential Sprint Fidelis settlement. We are currently representing patients throughout the United States in bringing claims due to the Medtronic lead recall.

Medtronic Defibrillator Lead Recall Lawsuit

For many of the 125,000 patients who have the Medtronic defibrillator that uses the Sprint Fidelis lead wires, the future is uncertain. The Medtronic defibrillator lead recall was announced following reports of lead wire fractures in patients.

Since the recall of the wires, which have been shown to have a higher incidence of fracture or breakage, patients must determine whether to keep the wires implanted or risk a surgery to have them replaced.

The Medtronic defibrillator helps the heart maintain a normal rhythm by monitoring the heartbeat and delivering a jolt of electricity if the rhythm is abnormal. Patients with conditions such as ventricular tachycardia or ventricular fibrillation may benefit from this device.

The device, which is implanted in the patient near the shoulder, has wires that connect from the device to the heart. Over time, the wires may become covered in tissue and are difficult to extract.

Initially, the Sprint Fidelis wires, or leads, were seen as an advanced product because they were narrower than the previously used leads. However, these thinner wires fracture at a higher rate. In some cases, the fractured wires produced unnecessary shocks, even when the heart was maintaining a regular rhythm. In other cases, the wires failed to produce a life-saving jolt when the heartbeat was irregular.

While patients work with their physicians to determine whether to remove or continue with the current leads, some patients have lingering effects even after the leads have been removed successfully.

For example, one patient who received unnecessary shocks from malfunctioning wires still experiences problems even after the wires were removed. As a result of receiving the unexpected shocks, he continues to have anxiety and heart palpitations.

Even patients who do not currently have problems with a Sprint Fidelis lead fracture must be on guard for future malfunctions. Although Medtronic puts the Sprint Fidelis failure rate at 3-6%, an independent study indicates that failure rates will rise significantly, and that in four years, 30% of Sprint Fidelis leads will fail.

Often when a product is recalled, it is a simple matter to discontinue using the product and to bring it in for replacement or repair. The Sprint Fidelis recall is very different from the norm. Instead, patients must make difficult and frightening decisions about their course of action. While the doctor can advice each patient on his or her specific options, we can provide consultation of a different kind.

We invite you to contact us to discuss your legal options. We represent all Sprint Fidelis Medtronic 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.