There are two types of implantable heart devices. The most common is a pacemaker which is designed for hearts that beat too slowly. Pacemakers sense when a heart rate falls and administers a relatively small jolt to the heart muscle to speed it back up.
A defibrillator is a small device implanted under a patient’s skin near the shoulder. Insulated lead wires are threaded through veins, connecting the defibrillator to specific parts of the heart. Defibrillators monitor heart rhythms. The technology itself is impressive and lifesaving. If a defibrillator detects an unstable heart rhythm, it gives an electric shock to the heart to shock the patient’s heart back to normal. Defibrillators’ electronic shock is usually approximately 750 volts – more than 100 times the shock delivered by a pacemaker.
You would think that a thousand little things could go wrong with a defibrillator or pacemaker but, historically, defibrillators have performed very well and have been shown they can be safe and effective. A 2006 study of more than 2.6 million pacemakers and defibrillators implanted between 1990 and 2002 found that only 0.65% malfunctioned.Who needs a defibrillator?
People who have problems with their heart rhythm are candidates for a defibrillator.What exactly is a defibrillator lead?
A defibrillator contains two parts. The first is a high tech computerized device that monitors the patient’s heart rhythms and makes the decision as to whether the electrical shock needs to be given. The leads are wires that doctors thread through the patient’s veins leading to specific parts of the heart. Leads stretch from the device through the veins to the heart. Essentially, the leads then are the messengers of information from the heart to the device itself. It both receives the information of the abnormal heart rhythm and sends the shock to the heart when an abnormal heart rhythm is detected.What kind of company is Medtronic?
Medtronic is a Fortune 500 company based in Minnesota that makes drugs and medical devices for heart conditions, brain disorders like Parkinson's, chronic pain, insulin pumps, and a whole host of other aliments. There is no question that Medtronic has provided products and services that have been of great help to a large number of people worldwide. Economically, Medtronic has been very successful. Although its stock price fell with news of the defibrillator lead recall, Medtronic's annual sales have more than doubled and its profits have almost tripled since 2001. As discussed below, it may well be this success led to its undoing in the Medtronic lead recall which is sure to cost Medtronic a fortune in loss of market share, lawsuit verdicts and settlements, and consumer and physician goodwill. [2013 Update: to be honest, I'm really not sure any of this came to pass. They just keep plugging along and making their money and the world looks past the bad corporate behavior.]What is the problem with the Medtronic leads?
The lead's failure can cause the defibrillator to either deliver an unnecessary electrical jolt or, creating the opposite problem, fail to give an electrical shock to a patient with an abnormal heart rhtyhm. In many, and hopefully most, cases, the defibrillators may be able to be reprogrammed without invasive surgery to minimize the risks of the defect. The problem is there is no reliable test that can predict which Medtronic leads will fracture in the future. Without symptoms, experts are not currently recommending that the recalled Medtronic lead be surgically removed because surgery to remove the Medtronic leads come with substantial risks although some progress is now being made in the surgical procedure to remove Medtronic leads.Is Medtronic the only defibrillator implicated in the concern over defective leads?
Medronic makes up the great majority of the estimated quarter of a million people who have Sprint Fidelis leads that were recalled. Guidant and St. Jude also had some defibrillators that had Sprint Fidelis leads. If you have a wallet card, you should look for the model numbers that appear alone or begin with 6949, 6948, 6931 and 6930.How many patients have suffered an injury from a Medtronic defibrillator with Spring Fidelis leads?
Medtronic has reported five patient deaths associated with fractured Sprint Fidelis leads and the FDA has 599 reports of malfunctions and injuries associated with the Fidelis leads as of January, 2007. The reports of lead malfunctioning appear to be increasing at an accelerating rate, as the reports of problems have outdistanced the number of people who are receiving new defibrillators, suggesting that the risks may increase over time. The FDA says that based on current information, fractures have occurred in less than 1 percent of Sprint Fidelis leads, but the FDA does not know if this rate of adverse events will remain constant or increase over the life of the Sprint Fidelis leads. The increasing number of reports and common sense tell you it is likely to be the latter. Even Medtronic estimates that about 2.3 percent of patients with the Sprint Fidelis lead, or 4,000 to 5,000 people, will experience a lead fracture within 30 months of implantation of the device. Given all that has happened, it is hard to take the company's estimate at face value.Why was the Sprint Fidelis lead on the market in the first place?
When these Sprint Fidelis defibrillator leads were first introduced, they did represent a technological advance, because the leads were 2.2 millimeters, almost half the size of what leads had historically been. This was considered an advance because doctors implanting defibrillators need to thread the lead wires through blood vessels, an easier task with a thin lead. The problem is that there was no history of safety. While there is still a lot of investigation that needs to be done by Medtronic lead recall lawyers, the early reports are that the FDA did not require clinical trial data on these leads.
The reality is that there is a lot of money in defibrillators for medical device companies. The cost to bring these products to market is incredibly expensive but the profit margins are remarkably high. Accordingly, medical device manufacturers, like Medtronic, rush these products because of the huge profits available if you can either gain or maintain market share. In 2001, Medtronic's annual sales have more than doubled, to $12.3 billion, and earnings have almost tripled, going from $2.41 a share from 85 cents. For Medtronic, its goal was not only increased profit but chasing down Johnson and Johnson as the world leader in medical devices. There is a feeling of déjà vu to all of this. Virtually the same thing happened just a few years ago. In June 2005, Guidant, which has since been bought by Boston Scientific, recalled its defibrillators that it rushed onto the market. That recall was arguably far less serious because at least a troubled defibrillator could be replaced. Lead wires are far more difficult to replace which makes this "recall" not much of a recall at all.How do I know if my Medtronic lead is defective?
Regrettably, there is no way to test whether a lead may fracture. Medtronic and the FDA are recommending that Medtronic defibrillator patients discuss with their doctors having their defibrillator settings adjusted because it may increase the likelihood that a fracture can be detected.I have a Sprint Fidelis lead implicated in the Medtronic recall but my lead has not fractured, nor have I had any problems. What should I do?
What you should do is see your doctor immediately. The FDA does not generally recommend the surgical removal of a fractured lead, because it is difficult to do for a number of reasons, not the least of which is that after years sitting in a vein, blood vessel tissue grows around the lead. But the reality is that patients should not be looking to the FDA or a lawyer for answer to this question, but rather should be talking immediately to their doctor. The good news is that if you are not having problems, it at least appears that you likely will not have problems. (That is easy to say when you do not have lead wires that are under intense scrutiny in your chest.)Has Medtronic made a settlement offer to resolve these claims?
Medtronic has settled most of the Medtronic cases. (Note: most clients have yet to receive compensation.) Frankly, the cases did not settle for a great deal of money, not because they were not meritorious but because of the Supreme Court ruling that - at least arguably - barred these claims (and because Congress refused to act to protect these victims). It is fair to say that no plaintiff received compensation that was fair given their injuries. Our law firm is no longer handling Medtronic lead recall cases. We leave this information up to provide information to people who have suffered and will suffer from this product.