Defibrillators

A heart defibrillator is a medical device designed to provide a small electrical charge to the human heart in order to resolve arrhythmia and restore the normal rhythm of heart contractions. This device is the most popular treatment for serious medical conditions such as ventricular tachycardia, ventricular fibrillation, and cardiac arrhythmias, all of which interrupt the natural rhythm of the heart and are life threatening conditions if left untreated.

Automated External Defibrillators (AEDs)

While some defibrillators are used internally and applied directly to the heart, other defibrillators function intravenously or externally. Manual defibrillators are sometimes used as form of resuscitation in cases of cardiac arrest and are often seen in film and television scenes depicting emergency medical care. In recent years, automated external defibrillators (AEDs) that can be used by a layperson with no medical training have begun appearing in many public places. An AED functions by automatically diagnosing the heart rhythm of an individual and prescribing the appropriate medical charge. The AED comes with instructions on how and where to place the accompanying pads on the body and delivers the appropriate jolt of electricity to restore a natural heart beat.

Automated Internal Cardiac Defibrillators (AICDs)

For patients who have a chronic condition that causes serious arrhythmias, an automated internal cardiac defibrillator (AICD) is frequently implanted. An AICD is a device similar to a pacemaker that delivers electrical jolts to the human heart whenever it detects a life-threatening arrhythmia. Many of the newer AICDs available to patients are advanced enough to make the distinction between serious arrhythmias like ventricular tachycardia and less threatening arrhythmias such as atrial fibrillation, allowing the devices to adjust the charge of the administered shock accordingly. However, defective programming and other design faults in some AICDs can occasionally cause the device to start misfiring and administer repeated, unnecessary shocks to the heart. This can result in serious pain and discomfort, and in some cases, this can lead to fatal arrhythmias or cardiac arrest. In fact, emergency medical personnel are now often equipped with a specialized magnetic device that is designed to disable a misfiring internal defibrillator.

Defects in AEDs

In the case of automated external defibrillators, there have many instances in which certain models of these devices have been recalled following repeated reports that the device was defective. In most cases, the problem existed with a fault in the design of the defibrillator that rendered it unable to deliver the necessary electrical charge when it detected a potentially lethal arrhythmia. Sometimes this can occur when there is a problem with the resistors in the defibrillator, in which case the device could not deliver the necessary electrical therapy. In other cases, the failure of a specific relay switch stopped the automated external defibrillator from building up the prescribed charge. Still other faulty automated external defibrillators are unable to wash out interference or background noise in order to correctly diagnose a patient’s heart beat, and there have been complaints of other defective components that result in dysfunctional electrocardiography (ECG) analysis.

Because automated external defibrillators are often used by laypeople as a form of emergency first aid, the Food and Drug Administration (FDA) has issued particularly severe warnings to users of these products when there appears to be a problem with a device. The failure of an external defibrillator during a medical emergency may easily result in death or serious injury if emergency medical personnel are unable to reach the affected patient in time.

2009 Recall of 300,000 CardioVive and Powerheart AEDs

Although the Cardiac Science Corporation issued a press release in November 2009 calling for the voluntary recall of some models of their automated electronic defibrillators, the FDA followed up the release just days later stating that the company was failing to adequately address the problem and that further action was necessary. The affected defibrillators include CardioVive models 92533, 92532, and 92531, as well as Powerheart models 9390E, 9390A, 9300P, 9300E, 9300D, 9300C, and 9300A. According to the FDA, these Cardiac Science automated electronic defibrillators are affected by a host of defective components, including an inability to recognize pad placement when delivering a charge and incorrect or interrupted electrocardiography. At the time of the initial press release from CardioVive, there were approximately 300,000 Cardiac Science defibrillators being used by the public that may be defective.

Injury and Deaths from Defective Sprint Fedelis AEDs

In the case of the October 2007 recall of the Sprint Fidelis Defibrillator, manufactured by Minnesota based manufacturer Medtronic Incorporated, the voluntary recall issued by the corporation and the FDA came too late to save the lives of a number of patients. Due to the fracturing in the wire leads of the defibrillators, the device delivered incorrect electrical shocks to patients or failed to work completely, resulting in serious injury or death to many individuals.

Sources:

  1. http://www.fda.gov/Safety/Recalls/ucm190605.htm
  2. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191426.htm
  3. http://news.minnesota.publicradio.org/features/2005/06/30_bensonl_guidant/

Medtronic Defibrillator Lawsuits

Numerous patients implanted with Medtronic Defibrillators that have the defective Sprint Fidelis lead wires sought the assistance of an attorney to find out what their legal rights were, resulting in many individual lawsuits and some class-action lawsuits.

There are numerous ongoing investigations involving Medtronic and these defective leads. However, patients affected by these Medtronic defibrillators have grounds for cases based on three issues:

(1) Medtronic never should have put a defibrillator with Sprint Fidelis leads on the market
(2) Medtronic should have acted more quickly to recall the defective defibrillator
(3) Manufacturers of medical devices, such as the Medtronic lead, have a duty to make safe products under the legal theory of strict liability

The first issue involves the Food and Drug Administration (FDA). Medtronic did not test the Sprint Fidelis wires extensively on humans before placing the product onto the market for the public because the FDA did not require them to do so. The FDA stated that because Medtronic was simply modifying an existing model, such testing was not required. Should the FDA have required Medtronic to conduct such clinical trials, the problems with the lead wires, more than likely, would have been discovered.

Because these trials did not occur, the defective lead went undetected. The FDA’s failure to require extensive testing does not negate Medtronic’s responsibility to create a safe product. Had the company conducted their own research into the stability of the leads, they may have caught the flaw and corrected it before placing the lead on the market.

Delayed Recall

Medtronic waited before carrying out the recall of the defective defibrillators. The company knew that the leads were fracturing at higher-than-usual rate for months before taking action. Before implementing a recall, Medtronic first blamed physicians for the problems, claiming that they were not implanting the lead properly. By January 10, 2007, there were 599 reports of injury filed, 204 of them for “inappropriate shocks.” In February 2007, there were 152 injury reports, compared to the 27 in February 2006.   After January 10, 2007, 1,030 more injuries were reported to the FDA, without any action taken. Dr. Robert Hauser of the Minneapolis Heart Institute states that he contacted Medtronic in early February 2007 about the problem and published a review of the injury cases in late March. The Heart Institute’s concern about the danger of these devices caused the institute to stop implanting the defibrillators in January.   Others began to notice the delay as well. Iowa Senator Charles Grassley wrote in a letter to the FDA stating, “Medtronic was aware of the potential lead fractures several months before suspending sales of the Sprint Fidelis defibrillation leads. I am concerned that action may not have been taken in a timely fashion in this case as well.”   Dr. William Maisel, who specializes in cardiac medical devices in Boston, told the New York Times that Medtronic’s warning to doctors in March, which told doctors of some early fracture reports, is another example of medical device companies’ failure to react to a problem. “What is frustrating here is that this was another situation that was predictable,” Dr. Maisel told the paper.   Although both the FDA and Medtronic were aware of the rising number of injuries, instead of taking action to correct the situation, Medtronic launched a million-dollar ad campaign titled “What’s Inside,” urging the public to inquire with their doctors as to whether they would be a good candidate for a Medtronic device or not.

Lawsuits Filed

There are more than 1,000 lawsuits filed against Medtronic for their faulty lead wire. Some of the cases are based on the legal premise of strict liability. This is a liability for which proof of a guilty mind in relation to one or more elements comprising the guilty act is not required. In other words, the court does not have to prove that Medtronic had a “guilty mind”—knew that their product was faulty—in order to prove that their lead wires were legally responsible for harming and killing others. To clarify further, anyone who is engaged in the stream of commerce of the lead wires (from Medtronic, the manufacturer, all the way down to the retailer that sold the hospital the defibrillator), may be responsible because the lead wires were defective and a person died. The court does not have to prove negligence but the injured patient has to prove that the product was defective. The theory goes on to reason that injuries from products may occur because the manufacturer failed to provide adequate instructions for use, and that they should be able to foresee that someone down the line will misuse the product and should make sure to design and manufacture a product so that injuries do not happen.

At this time, Medtronic has not yet settled any of the Sprint Fidelis cases. Many involved in medical malpractice and other areas of personal injury law predicted that the Medtronic lead wire cases would settle out of court, but court decisions have proved these predictions unfruitful. On May 18, 2009, a U.S. district court dismissed a lawsuit against Medtronic because the FDA had previously approved the Sprint Fidelis defibrillator lead wires connected with patient deaths. This approval occurred because the Sprint Fidelis lead wires were a modification of the previous, more dependable, Sprint Quattro model. Even though this case and others against Medtronic were dismissed, the principle of pre-emption is likely to be a legal controversy for some time, especially if the FDA approves other devices that later are alleged to be unsafe or defective.

Currently there are many law firms available to the public that devote their practices to representing clients injured by the Medtronic Sprint Fidelis lead wire.

Sources:

  1. Defibrillators (Implantable). Retrieved December 24, 2009 from http://www.medtronic.com/our-therapies/defibrillators/index.htm
  2. Medtronic Defibrillator: What to Do If You Have One. Retrieved December 24, 2009 from http://www.defibinfo.com/medtronic-defibrillator

Medtronic Defibrillators Safety Concerns

In October 2007, Medtronic issued a recall of their defibrillators that had Sprint Fidelis lead wires because the leads were fracturing at an alarming rate, causing 5 deaths and more than 1,000 injuries between 2004 and 2007, with more deaths occurring through 2009.

This recall affected Sprint Fidelis model numbers 6930, 6931, 6948, and 6949. Lead wires on ICDs pass information from the ICD to the heart, and vice-versa, allowing the defibrillator to send a life-saving electrical shock to the heart should it lapse into an arrhythmia. Without a reliable lead wire, many dire consequences may occur.

Medtronic began producing and distributing implantable cardioverter-defibrillators—ICDs—with new Sprint Fidelis lead wires in 2004. These leads were a modification of their existing Sprint Quattro model, a very successful and popular lead wire placed in their previous defibrillators. The Sprint Fidelis line sought to increase comfort by utilizing a new, ultra-thin wire, but did not test the new in patients before putting it on the market.

The FDA saw the new leads as a modification of an existing model and did not require testing before public distribution. Medtronic states that approximately 4,000 to 5,000 people with a Sprint Fidelis lead will have a fracture within 30 months of having their defibrillator implanted.
The consequences of a broken lead wire can be deadly. If a break does take place, three instances may result: the implanted defibrillator will beep, alerting the patient to seek immediate medical care, the fracture will create a massive electric shock that causes the patient extreme and sudden chest pain, or the fracture will drain the ICD’s battery, causing it to fail to deliver the necessary shock. Any of these situations, without prompt medical attention, can lead to death if the patient’s heart goes out of a normal rhythm.

The fractures occurred in two specific areas, the distal portion of the lead, affecting the anode (ring electrode) and the anchoring sleeve tie-down, mainly affecting the cathode (helix tip electrode), and sometimes the high voltage conductor. Breaks occurring near the high voltage conductor caused the ICD to be unable to deliver the necessary defibrillating shocks while anode or cathode conductor fractures (at either location) caused increased impedance, over sensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output.

There is evidence that Medtronic knew about the problems with the new lead wires but did not act quickly enough to remedy the situation. By 2007, five patients died as a direct cause of broken leads and the problems associated with them while more than 1,000 other patients filed injury reports with other grievances related to fractured Sprint Fidelis lead.

These injury reports included 204 instances of unnecessary shocks before January 10, 2007 and 563 after that date relating to delayed or absent shocks when needed, associated chest pain, fainting, irregular heartbeats, and a myriad of other complaints. By January 10, 2007, there were 1,629 complaints, 767 of those due to inappropriate electrical shocks from the ICD.
While Medtronic is not discussing the reason these lead wires broke at such alarming rates, it is most likely that the super-thin design of the wire is not strong enough to sustain the stresses encountered during placement and the recovery period. Many questions arouse regarding why Medtronic did not issue their recall earlier, saving ICD patients the worry about their particular device and saving those with broken leads the pain of unnecessary shocks and other associated events
A Recall is Issued
In October 2007, Medtronic issued a recall, sending patients letters telling them that they were likely to suffer more from the replacement of the wires than if they left the device as is, and another letter to physicians stating that the leads could fracture at a “higher than expected” rate. The letter continued on to recommend that doctors watch over their ICD patients very closely for signs of fracture.
The only way to fix a broken lead wire is to replace it, a very dangerous and invasive surgery that involves removing the faulty wire and replacing it with a more reliable one. The problems with the surgery likely include extensive tissue damage, especially in patients who have had their devices implanted for some time, as the body eventually grows new tissues around the lead wire, totally encompassing the wire.
Recovery from the procedure is demanding, and medical professionals recommend only having it done if there is evidence that there is damage to the lead wire. In 2009, the death toll associated with the Sprint Fidelis leads rose to 13, including four associated with extracting the leads. It is impossible to tell whether a patient has a Sprint Fidelis wire without proper examination, so physicians and the FDA recommend that patients with an ICD consult their doctor as soon as possible for an exam. Medtronic is still stating that the best treatment is to leave the faulty leads in place unless fractured, and then, should extraction become necessary, an experienced surgeon should perform the surgery.

Medtronic Defibrillator Recall

Defibrillators save lives by maintaining regular heartbeats in patients with conditions such as ventricular fibrillation. One of the most widely used defibrillators in the United States is the Medtronic defibrillator, a device surgically implanted into the body of a patient to monitor the rhythm of the heart, correcting the rhythm if the heart begins to beat too fast. The part of the defibrillator that connects to the heart is a lead wire.

The lead wire in 90 percent of Medtronic’s defibrillators since 2004 was the Sprint Fidelis lead wire, placed inside of some 268,000 patients, according to the Wall Street Journal. Within the first few years of use, patients with Medtronic defibrillators that contained the Sprint Fidelis lead wires ended up in hospitals with broken lead wires. When this lead wire breaks, it is possible that the lead wire will emit a large and painful shock and the broken lead wire can prevent the defibrillator from sending an essential, lifesaving jolt to the heart.

Defibrillator lead fractures typically occur near the generator, at fixation points (such as the point of venous entry), and at sharp bends in the lead, and these breaks are rare.

Researchers at Medtronic developed the Sprint Fidelis lead wire to replace the Sprint Quattro. The new wire was much thinner than the older version, and not thoroughly tested in humans before becoming widely available on the market. While Medtronic has not disclosed the precise mechanism of how these Sprint Fidelis lead fracture failures occurred, it appears that the defect is due to the small diameter of the coil and conductors in the lead. Because of this, the lead is subject to stress damage both during and after implanting the defibrillator. A lead fracture occurs when the conductor is critically overstressed. It quickly became clear that this ultra-thin design was not as resilient as the previous model, as patients from across the country began coming to their doctors with fractured Sprint Fidelis lead wires.

Deaths and Injuries

Doctors connected the Sprint Fidelis to five deaths and more than 1,000 more patients suffered a wide range of side effects from the dangerous leads. The only solution for the problem of fractured lead wires is a surgery to replace the lead wire which is not a simple task, as the procedure can tear the tissue of the blood vessels and heart. Due to these hazards, doctors and the U.S. Food and Drug Administration (FDA) recommend that patients with these defibrillators not have the surgery to remove the faulty wire unless they were broken, leaving approximately 235,000 patients with defibrillators with defective lead wires still inside their chests, but not fractured. In a letter to patients in 2007, Medtronic informed patients that those with a Sprint Fidelis lead wire “…are more likely to experience complications from removal than from a problem with a Sprint Fidelis lead,” leaving patients and their doctors faced with a complicated decision.

Because of the issues with the leads, Medtronic stopped producing and selling them. Five people died because of fractures in their Sprint Fidelis leads, leading to unnecessary electrical discharges or defective sensing and capturing of electrical cardiac impulses. The FDA investigated the situation, and found that more patients were affected than the company originally thought.

Recall of Medtronic Defibrillator

Beginning in October 2007, Medtronic recalled the Sprint Fidelis leads, model numbers 6930, 6931, 6948 and 6949, and requested that doctors closely monitor their patients with these leads implanted. As a result, Medtronic put out a voluntary recall of these unsound leads to limit the further latent harm for patients.

Many injured patients retained lawyers to help them understand their legal rights and seek restitution from Medtronic. At the time of this writing, Medtronic has not yet settled any of the pending lawsuits nor have they settled any of the defective lead cases.

Sources:

  1. Steiner RM, Morse DP, Tegtmeyer CJ. Pacemaker lead pseudo-fracture. Radiology 1982;143:793.
  2. Weissman JL, Kanel KT. Ligature causing pseudofracture of a cardiac pacemaker lead. AJR 1996;166:464-465.