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Medtronic Sprint Fidelis Lead Recall Lawsuit Information
On October 15, 2007 the Food and Drug Administration released the following statement:
Statement on Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads
Statement by Daniel Schultz, M.D., director of the Center for Devices and Radiological Health:
Click here to download the latest version of Flash Player.Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.
These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.
Defibrillators are life-saving products for patients with a heart rhythm abnormality. We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect. However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.
Background:
Today, Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today's action.
If you need to contact us about this matter, please click here for a free online consultation.
Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.
When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don't know if this rate of adverse events will remain constant or increase over the life of these leads.
FDA considers Medtronic's action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action. 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.
The leads continue to function properly in the vast proportion of patients. Although there is no test to predict which lead will fracture, FDA agrees with Medtronic's recommendation 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 fracture will be detected before a patient is harmed.
Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks 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.
Patients should recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients have reason to believe that they have a Sprint Fidelis lead or if they do not know the model of their lead, they should contact their health care professional.
FDA will continue to monitor information on these devices and will take whatever other actions may be necessary.
Medtronic Recalls Sprint Fidelis Cardiac Leads
Food and Drug Administration: Questions and Answers for ConsumersWhat are Sprint Fidelis Leads?
Manufactured by Medtronic, Inc., Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur.How do defibrillators work?
Defibrillators monitor heart rhythms. They deliver an electrical shock or rapid pacing to restore normal rhythm when life-threatening, irregular heartbeats are detected. These devices keep the heart from going too fast. They are surgically implanted for patients who are at risk of sudden cardiac arrest.What is Medtronic announcing about the Sprint Fidelis Leads?
Medtronic, Inc., is announcing that it is voluntarily suspending worldwide distribution of the Sprint Fidelis family of defibrillation leads. This includes four Sprint Fidelis Models: 6930, 6931, 6948, and 6949. FDA considers this removal action to be a medical device recall. Medtronic is advising physicians to stop implanting the leads and to return unused products to the firm.How do I know if I have a Sprint Fidelis lead?
You may have a patient card that identifies the implanted devices you have. If you have any uncertainty about your devices, you should contact your physician.Does this action affect other Medtronic devices?
This action does not affect patients who have Medtronic devices that are pacemakers. While defibrillators keep the heart from going too fast, pacemakers keep the heart from going too slowly. This action also does not affect patients who have Medtronic ICDs or CRT-Ds without a Sprint Fidelis lead.What is a medical device recall?
A recall is an action taken when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A recall for an implantable medical device does not always mean that the device has to be removed.Why are the Sprint Fidelis Leads being recalled?
The devices are being recalled because of the potential for lead fractures. These electronic wires are prone to fracture in a small number of patients. This could cause the defibrillator to deliver unnecessary shock or to not operate at all. Some deaths and other serious injuries have been reported in which a fracture in a Sprint Fidelis lead may have been a possible or likely contributing factor.How many people have had this device implanted?
As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide, including 172,000 Sprint Fidelis leads implanted in the United States.
If you need to contact us about this matter, please click here for a free online consultation.
Medtronic suspended sales and recalled all unused Sprint Fidelis leads, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with defective Sprint Fidelis leads are being told to leave the components in place unless they fracture.
When Medtronic issued the Sprint Fidelis lead recall, it was estimated that about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted. Apparently, it was a problem that the company had known about for months. Since it was introduced to the market in 2004, there have been 599 reports of lead fractures as of January 2007. And it seems as though the fracture problems became worse over time. In the first two months of 2006, there were 27 reports of the Sprint Fidelis lead fracturing. But in the first two months of 2007, there were 152 reports. And since January 10, 2007, there have been a staggering 1,030 reports of fractures.
Shortly after the Sprint Fidelis lead recall, it was learned that the FDA had not required extensive testing of the vital defibrillator
component before it went on the market. Although the agency had required Medtronic to test an earlier version of a defibrillator lead in patients before approval, it had not required the company to do so for the defective Sprint Fidelis lead. That was because officials at the FDA had determined that the Sprint Fidelis lead was not a significant enough change from the design of its predecessor. Instead, the FDA required the Sprint Fidelis lead to pass only tests intended to identify design flaws. Those were principally mechanical stress tests meant to recreate the pressures in the body. The FDA is trying to figure out why those tests did not pick up the defects in the Sprint Fidelis lead.
Some medical experts have questioned the FDA’s decision not to put the defective Sprint Fidelis lead through more clinical tests. Though its predecessor, the Sprint Quattro, has a good performance history, the Sprint Fidelis lead is a significantly thinner wire. Many believe that thinness made the defective Sprint Fidelis lead more apt to fracture.
The issues that the Congressional Committee is investigating include the FDA’s decision not to subject the defective Sprint Fidelis lead to more rigorous testing, and why all defibrillator leads are not subject to the same level of scrutiny as the heart devices themselves.
If you need to contact us about this matter, please click here for a free online consultation.
Judicial Panel on Multi-District Litigation Transfers all Medtronic Sprint Fidelis Cases filed in Federal Courts to District of Minnesota
• February 23, 2008
The Judicial Panel on Multi-District Litigation issued a transfer order, transferring all Medtronic Sprint Fidelis cases filed in various federal courts to the District of Minnesota.
On October, 15, 2007, Medtronic Inc. announced it was recalling its Sprint Fidelis leads from the worldwide market due to a risk of fracture, which can potentially cause a defibrillator to either fail or deliver unnecessary shocks.
The recall involves the following Medtronic defibrillation leads:
* Sprint Fidelis 6930
* Sprint Fidelis 6931
* Sprint Fidelis 6948
* Sprint Fidelis 6949Most defibrillator and pacemaker patients have an identification card that lists the model and serial numbers of their device and leads. If your device identification card contains the numbers 6930, 6931, 6948 or 6949, it is likely you have a recalled lead. If you are uncertain if you have a recalled implanted sprint fidelis you can contact our office for a free consultation.
If you need to contact us about this matter, please click here for a free online consultation.
