Medtronic Lead Wire | FDA Approval New Defibrillator Lead

Medtronic has received FDA approval for a new defibrillator lead – the Sprint Quattro Secure lead. Last October, a Medtronic recall of its Sprint Fidelis leads was announced following reports of several patients’ deaths due to lead fractures. The following is Medtronic’s announcement of their new defibrillator heart lead.

Medtronic Announces FDA Approval and Market Availability of Sprint Quattro Secure® S Single Coil Defibrillation Lead

MINNEAPOLIS – Dec. 3, 2008 -Medtronic, Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Medtronic Sprint Quattro Secure® S single coil defibrillation lead (Model 6935) for use with implantable defibrillators in patients at risk for dangerous tachyarrhythmias (fast heartbeats) and sudden cardiac arrest. This new defibrillation lead is an addition to the Sprint Quattro® family that is supported by more than seven years of post-market performance data¹. It provides an option for physicians who prefer a specific type of lead for patients with unique anatomies and is designed to help reduce tip pressure. The U.S. approval and market release of this single coil option follows its recent European approval and launch.

The Medtronic Sprint Quattro Secure S lead is designed with an 8.6 French diameter lead body (approximately 2.8 millimeters in diameter). A thin wire inserted into the chambers of the heart through blood vessels, the lead is compatible with any Medtronic implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), which are stopwatch-sized devices that administer electrical shocks or painless pacing therapy to stop dangerous ventricular arrhythmias.

” I prefer a single coil lead for my patients and am looking forward to having this new option available,” said Michael Lincoln, M.D., with Holy Cross Hospital in Silver Spring and NIH Heart Center at Suburban Hospital in Bethesda, Md. “Based on my own clinical experience and the breadth of long-term clinical performance data, I believe the Sprint Quattro family of defibrillation leads is highly reliable.”

“The Sprint Quattro family of defibrillation leads is highly respected in the cardiac community,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “We are pleased the FDA has approved this single coil option, which gives physicians another choice in order to deliver the appropriate treatment to each individual patient.”

In conjunction with this introduction, Medtronic is extending its defibrillation lead warranty to a lifetime limited warranty, which covers all defibrillation leads implanted in the United States on or after Dec. 1, 2008. Under the lifetime warranty, Medtronic will provide a replacement lead at no charge if the lead does not perform according to specification and meets other specified warranty criteria. It also will reimburse patients for certain unreimbursed medical expenses in the amount specified in the warranty. Defibrillation leads implanted before Dec. 1, 2008 are covered by Medtronic’s current five-year limited warranty. Medtronic has offered a lifetime limited warranty on pacing leads in the United States since 1984.

Sprint Fidelis 6949 Defibrillator Leads | Medtronic Recall Lawsuit

If you or someone you know has received a Sprint Fidelis defibrillator lead 6949 you may have important legal rights. Many patients have experienced a lead fracture which can cause painful and sometimes life-threatening shocks to the heart or alternatively not provide a shock when needed. We are currently representing patients who have a defective Medtronic 6949 lead in filing individual Medtronic recall lawsuits.

Following the death of five patients Medtronic removed its Sprint Fidelis 6949 lead along with models: 6930, 6931 and 6948. A lead fracture in the defibrillator wire can cause serious problems by either sending an unnecessary jolt to the heart or not operating at all.

Medtronic 6949 Lead

U.S. Market Release September 2004
Serial Number Prefix LFJ
Type and/or Fixation Transvenous, Vent, Defib and Pace/ Sense, Screw-in
Polarity True Bipolar / Two Coils
Steroid Yes
Estimated U.S. Implants 188,200
Estimated U.S. Active 157,900

Fields Law Firm is a Minneapolis, Minnesota based law firm that is working with patients affected by the Medtronic recall throughout the United States.

We represent all Medtronic 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 at 1-888-343-5375 or fill out our short online contact form and an attorney will contact you to answer any of your questions.

Medtronic Recall Class Action Lawsuit Information

On October 15, 2007 a Medtronic recall was issued due to reports of at least five patient deaths linked with defective defibrillator leads. The heart leads are susceptible to fracture which can then cause the defibrillator to deliver unnecessary shocks or not operate at all. Following the recall no more Sprint Fidelis leads were sold or manufactured. In addition, remaining inventory of the Medtronic leads was removed from hospitals. Sprint Fidelis leads model numbers 6930, 6931, 6948 and 6949 are affected by the recall.

Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators are used to help shock the heart in order to treat abnormal heart rhythms that can cause the heart to suddenly stop. When a Medtronic lead wire fractures of breaks the lead can send false signals that create inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.

Approximately 268,000 Sprint Fidelis leads have been implanted worldwide. Patients with these recalled leads continue to suffer from lead fractures requiring surgery to replace the defective leads. Currently, there is no test that can predict which lead will fracture and the FDA does not recommend the routine removal of leads due to the risk of such surgeries.

If you or a loved one has questions regarding the Medtronic recall please contact us and a Sprint Fidelis class action attorney can help answer your questions. We offer a free, confidential no-obligation consultation to individuals and families affected by the Medtronic heart lead recall.

Medtronic Sprint Fidelis 6949 Lawsuit Class Action Recall Updates | Attorney Lawyer

The Minneapolis Heart Institute conducted a study of the Medtronic Sprint Fidelis 6949 lead and determined that the lead had a greater failure rate compared to the Quattro lead. In October 2007 Medtronic announced a recall of Sprint Fidelis lead 6949 along with leads 6948, 6930 and 6931.

Medtronic Lead Failure

Minneapolis Heart Institute Foundation Study

Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead.

Hauser RG, Kallinen LM, Almquist AK, Gornick CC, Katsiyiannis WT.

BACKGROUND: We have observed a higher than expected rate of Sprint Fidelis model 6949 lead failures in our practice.

OBJECTIVE: The aim of this study was to assess the performance of small-diameter Sprint Fidelis high-voltage ICD leads.

METHODS: The actuarial survival of Sprint Fidelis model 6949 leads implanted at our center was compared with that of the Sprint Quattro Secure model 6947. The United States Food and Drug Administration Manufacturers and User Facility Device Experience (MAUDE) database was searched for Sprint Fidelis models.

RESULTS: The survival of 583 Sprint Fidelis 6949 leads implanted at our center between September 2004 and February 2007 was significantly less than 285 Sprint Quattro Secure model 6947 leads implanted by us between November 2001 and February 2007 (P = .005). Six patients presented with Sprint Fidelis lead failure 4-23 months after implant. Five of the six patients experienced multiple inappropriate shocks associated with pace-sense conductor and coil fractures; the sixth patient had a fixation mechanism failure. The MAUDE search rendered reports for 679 Sprint Fidelis leads. The most frequent complaints or observations were inappropriate shocks (33%), high impedance (33%), and fracture (35%). Of 125 leads analyzed by the manufacturer, 62 involved fracture of the pace-sense conductor or coil and the high-voltage (defibrillation) conductor.

CONCLUSIONS: The Sprint Fidelis high-voltage lead appears to be prone to early failure. Its use should be limited until the failure mechanism is identified and corrected. Patients should be evaluated quarterly, and automatic lead test features should be enabled. While more data are needed, routine prophylactic replacement of intact, normally functioning Sprint Fidelis leads does not appear justified. PMID: 17599673 [PubMed - indexed for MEDLINE]

Reprinted courtesy of PubMed.gov, a service of the U. S. National Library of Medicine and the National Institutes of Health

If you or a loved one has questions regarding the Medtronic Sprint Fidelis 6949 lead recall please contact us and a Sprint Fidelis lawsuit attorney can help answer your questions. We offer a free, confidential no-obligation consultation to individuals and families affected by the Medtronic recall.

Sprint Fidelis Lawsuit Status | FDA News Lead Fractures

On September 4, 2008 the FDA released a News Alert regarding a software update from Medtronic that is supposed to help detect Sprint Fidelis lead fractures. Approximately 268,000 Sprint Fidelis lead have been implanted in patients worldwide. The Medtronic recall of heart leads included four Sprint Fidelis models: 6930, 6931, 6948 and 6949.

Recalls Sprint Fidelis

FDA News

FOR IMMEDIATE RELEASE
September 4, 2008

FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures

The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company’s Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.

“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health, FDA. “While the software doesn’t fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”

Implantable defibrillators are used to treat patients at risk of experiencing life-threatening heart rhythm abnormalities. Should an abnormality occur, the defibrillator delivers a pulse of energy through a lead, a thin electronic wire, shocking the heart back into normal rhythm.

The Sprint Fidelis lead, the subject of an October 2007 Medtronic recall, was prone to fracture in a small number of patients, potentially causing the lead to deliver unnecessary shocks or not operate at all. Most of the patients with the Sprint Fidelis lead still have the device implanted because of the surgical risk associated with removal, and are being monitored by their health care providers for potential fracture.

Medtronic’s new software feature, called the Lead Integrity Alert, issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Medtronic has agreed to actively monitor the performance of the new software feature in actual use, which will allow both the company and FDA to ensure that the device is protecting patients as intended.

If you or a loved one has questions regarding the Medtronic Sprint Fidelis lead recall please contact us and a Sprint Fidelis class action lawsuit attorney can help answer your questions. We offer a free consultation to individuals and families affected by the Medtronic recall.

Medtronic FDA Recall | Sprint Fidelis Lawsuit News

It is estimated that 250,000 patients with Sprint Fidelis heart leads will be affected by the Medtronic FDA recall. Patients with Medtronic leads implanted are at risk of having a lead fracture which can lead to extremely painful shocks or not receiving any shock when they are needed. Recently, the government and a small group of doctors have questioned the current system that is in place where manufacturers pay doctors to consult for their company.The pressure is increasing on medical device manufacturers like Medtronic to be more open about their financial relationships with doctors and clinics. The Star Tribune published a new series of investigative reports that focus on the relationship between medical device manufacturers and payments to doctors.

Through evidence gathered during a whistleblower lawsuit, investigators are learning the scope of the common industry practice of doctors, who are paid consultants, recommending specific products over competitors’ products. Senators Charles Grassley and Herb Kohl have sponsored a bill to bring payments to doctors out into public scrutiny.

If you or a loved one has questions regarding the Medtronic Sprint Fidelis lead recall please contact us and a Medtronic recall lawsuit attorney can help answer your questions. We offer a free consultation to individuals and families affected by the Medtronic recall.

Sprint Fidelis Lawsuit Status | Medtronic Recalls Heart Leads

Following the Medtronic recall of their Sprint Fidelis leads the Food and Drug Administration (FDA) has been involved keeping patients informed of new information regarding the defective leads as it becomes available. The following Question and Answer sheet was released by the FDA to help consumers affected by the Medtronic lead recall.

Medtronics Lead Recall

Medtronic Recalls Sprint Fidelis Cardiac Leads
Questions and Answers for Consumers

What 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.
What should patients do if they have had a Sprint Fidelis lead implanted?
Patients who have had the Sprint Fidelis lead implanted should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.
Patients should not routinely seek removal of the device. The risks of removal in most patients exceed the small risk of lead fractures. Therefore, it is generally recommended to leave functioning leads in place. There are two alternatives to removing the lead. One is to continue using the lead while monitoring closely for signs of fracture. A second is to surgically add a replacement lead. Adding a replacement lead does not require removing the Sprint Fidelis lead. If the Sprint Fidelis is left in a patient without being used, it must be “capped”, which means covering the tip with a small plastic insulation.
Patients can call Medtronic at this toll-free number: 1-800-551-5544, ext. 41835.

What additional advice has been given to protect patient health?
Medtronic has provided guidance to physicians on how to reduce the risks in affected patients and ensure that devices are set to more effectively monitor for potential fractures. These patient management recommendations are available at http://www.medtronic.com/product-advisories/index.htm

How should problems with Sprint Fidelis leads be reported?
Problems should be reported to FDA’s MedWatch Adverse Event Reporting program.

If you or a loved one has questions regarding the Medtronic Sprint Fidelis lead recall please contact us and a Medtronic recall lawsuit attorney can help answer your questions. We offer a free consultation to individuals and families affected by the Medtronic recall.

Medtronic Lead Recall Testimony | Sprint Fidelis News

On June 11, 2008 Bridget Robb testified before the Senate Judiciary Committee regarding her experience with the Medtronic lead recall. Ms. Robb suffered 31 shocks as a result of a defective Sprint Fidelis lead manufactured by Medtronic. Ms. Robb tells her story and shows how important it is for manufacturers of dangerous and defective products to be held accountable rather than be protected by preemption.

Statement of Bridget Robb
Gwynedd, PA

Before the
Senate Judiciary Committee

For a hearing entitled
“Short-change for Consumers and Short-shrift for Congress? The Supreme Court’s Treatment of Laws that Protect Americans’ Health, Safety, Jobs and Retirement”

Wednesday, June 11, 2008

Chairman Leahy and Members of the Senate Judiciary Committee:

Thank you for the invitation to speak on the topic of laws that protect Americans’ health and safety. In a time when big business and corporate profits seem to take precedence over individuals’ rights, we tend to forget the reasons why certain laws were in fact enacted, and why it remains important for people who have been injured by defective products, to be able to hold companies accountable and to have their day in court. I am here today not only because of my own tragedy but also to protect the rights of those who have or may suffer similar events such as mine.

My name is Bridget Robb. I am a thirty-four year old mother and resident of Gwynedd, Pennsylvania. On December 31, 2007, I suffered greatly and thought I was going to die because of a defective heart device implanted in my body. I am thankful to be here today and to be able to share my experience with you.

Approximately four (4) years ago, I was diagnosed with non-ischemic, viral cardiomyopathy and congestive heart failure. In May 2005, to prevent me from dying from a fatal arrhythmia, I had a Medtronic cardiac defibrillator with pacemaker implanted in my chest. This heart device is a small metal case that contains electronics and a battery. Its components work much like a pacemaker, but unlike a pacemaker, an ICD delivers an electrical shock to the heart when the heart rate becomes dangerously fast. My particular device combined a pacemaker and ICD in one unit.

On December 31, 2007, I was awoken from my sleep by a series of shocks to my heart which felt as if a cannon was being repeatedly shot at my chest at close range. Along with these recurrent shocks was a strong, electrical current racing through my body. After feeling the first shock, I immediately phoned 9-1-1 for help. My six-year old daughter, Emma, had snuck into bed with me that night and was present during this horrific experience. I remember Emma being scared and confused. She crouched down in front of me hugging her cat, saying “Mommy’s dying.” She was present during the entire seven minutes that I was on the telephone with the 911 operator until the EMS arrived. I cannot imagine how terrified she must have been to see her mother in such pain.

The doctors have told me that I received a total of thirty-one (31) inappropriate shocks to my heart in a matter of minutes that morning. Each time I was shocked, I saw my life flash before my eyes. At one point, I began to pass out and thought that I would never see Emma again.

I later learned that the inappropriate shocking and electrical feeling throughout my body was caused by a defective cardiac lead implanted in my heart, the Sprint Fidelis lead manufactured by Medtronic. A lead is a thin wire which connects the ICD to the heart and delivers the actual shock to the heart when it is beating too fast. Medtronic’s Sprint Fidelis lead was recalled on October 15, 2007, because of its potential to fracture. Unfortunately, Medtronic never notified me that my lead was recalled and I did not learn of the recall until after this “life-saving” medical device seriously hurt me.

Since this terrifying experience, my health had declined significantly. I have been visiting doctors almost weekly for follow-up appointments and testing, and have suffered from severe anxiety. I have since undergone surgical replacement of my defibrillator and the defective lead, and a second surgery to revise the lead. My second surgery resulted in an extended hospital stay where I had to undergo a blood transfusion. As you would expect, I risk serious harm each time another procedure is performed. Even though Medtronic’s defective device caused my injuries, my health insurance plan has been paying for the cost of my medical care.

I would like to have the opportunity to hold Medtronic accountable for the injuries that I suffered that day and the emotional after-effects that I continue to experience on a daily basis. Medtronic knew that its Sprint Fidelis lead was faulty, yet the company never took reasonable steps to notify me that this lead needed to be replaced. Instead, I suffered indescribable pain that day and continue to suffer from the emotional toll of my near-death experience.

However, my attorneys tell me that a jury may never hear my case due to a legal doctrine known as “preemption,” which the Supreme Court recently discussed in another Medtronic medical device case,
Riegel v. Medtronic
. In that case, the Supreme Court found that any claims brought by people injured by another Medtronic device were “preempted” and that the company would have complete immunity from any claims brought against it given that the FDA had approved the device. My attorneys are
concerned that the
Riegel
decision also may apply to my case and, as a result, I would have no recourse for my injuries. I find this discouraging and demoralizing.

In addition, the considerable costs for my healthcare have been shifted from Medtronic, the company that knew about this problem but failed to take action, to my health insurance provider. This may result in an increase in the cost of my insurance. It is wrong to shift the cost of medical care from the responsible party to private insurers, patients, and in some cases to taxpayer sponsored programs like Medicare and Medicaid.

Therefore, I am asking Congress to pass legislation to ensure that victims of faulty medical devices, like me, will continue to have the ability to hold a medical device manufacturer accountable for their injuries. I find it hard to believe that Congress ever intended to prohibit me from even having the opportunity to go to court to obtain justice. Thank you for your attention to this critical issue. I am happy to answer any questions that you may have.

If you or a loved one has questions regarding the Medtronic Sprint Fidelis lead recall please contact us and we can help answer your questions. We offer a free consultation to individuals and families affected by the Medtronic recall.

Medtronic Recall Lawsuit | Sprint Fidelis Defective Lead Attorney Lawyer

Following the Medtronic recall of their Sprint Fidelis heart leads the FDA released a statement covering the background of the Medtronic leads and recommendations.

Neither the 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. The following Medtronic statement accompanied their letter to physicians on October 15, 2007.

Sprint Fidelis Lead Extraction Risks

October 2007
This attachment accompanies Medtronic’s physician letter dated October 15, 2007 and provides information concerning risks inherent in lead extractions.

Medtronic’s Independent Physician Quality Panel believes it is inappropriate to prophylactically remove Sprint Fidelis® leads except in unusual individual patient circumstances. We support this position.

Extraction of chronic leads entails substantial risks of patient morbidity and mortality. Reported complications1 include: lead breakage and migration; avulsion of veins, myocardium or the tricuspid valve; tears of the myocardium or veins; hemothorax, tamponade, perforation, emergency cardiothoracic surgery, pulmonary emboli, and death.

In evaluating whether to extract any cardiac lead, physicians must weigh the risks and benefits of leaving the lead in place in comparison to those of removal. Major complications from lead extraction, defined as death or the requirement of a significant surgical intervention, have been reported in multiple series to be in the range of 1.4-7.3% of patients.2,3 Factors reported to increase the risk of major complications include: duration of implant, female gender, and large removal sheaths.4,5

Medtronic Sprint Fidelis performance data indicate all-cause lead survival of 97.7% at 30 months (SLS, Medtronic CareLink® Network analysis). High voltage conductor fractures could result in the inability to deliver defibrillation therapy. Anode or cathode conductor fractures at either of the primary fracture locations may present clinically as increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output. Utilization of the patient management recommendations will increase the likelihood that a fracture will be detected by Patient Alert^TM and/or Medtronic CareAlert® notifications (see Appendix C) and decrease the likelihood of inappropriate therapies. Based on current information, we have identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. (0.0018% of approximately 268,000 implants worldwide). By comparison, the risk of major complications (cardiac surgery or death) with lead extraction is 1.4-7.3%.

It has been reported that limited physician experience (< 50 procedures) may significantly increase the risk of complications from extraction.6 For this reason, Medtronic’s Independent Physician Quality Panel recommends that if a lead requires removal, the procedure be performed by a physician with extensive lead extraction experience.

These recommendations are consistent with the HRS Policy Statement on recommendations for extraction of chronically implanted leads.7

References
1. Byrd CL, Wilkoff BL, in Clinical Cardiac Pacing and Defibrillation, Ellenbogen, Kay and Wilkoff editors. WB Saunders 2000, Techniques and Devices for Extraction of Pacemaker and Implantable Cardioverter Defibrillator Leads: 695-709.
2. Byrd et al, Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute. PACE. 1999;22(9):1349-1357.
3. Bracke et al, Lead extraction for device related infections: a single-centre experience. Europace May 2004; 6(3):243-247.
4. Byrd et al. PACE. 1999;22(9):1349-1357.
5. Kennergren et al, Laser-assisted lead extraction: the European experience. Europace. August 2007; 9(8):651-656.
6. Byrd et al. PACE. 1999;22(9):1349-1357.
7. NASPE Policy Statement: Recommendations for Extraction of Chronically Implanted Transvenous Pacing and Defibrillator Leads: Indications, Facilities, Training. Love CJ, Wilkoff BL, et al. PACE. 2000; 23, 544-551.

If you have questions or concerns, please contact your Medtronic Representative or Medtronic Technical Services at 1-800-723-4636 (US).

If you or a loved one has been injured by a defective Medtronic defibrillator lead please contact us for a free consultation and case review. A Medtronic recall class action attorney can go over your legal rights and options and evaluate any potential claims you may have. You may be entitled to compensation and we can help.

Medtronic Heart Lead Recall | Class Action Lawsuit

On October 15, 2007, Medtronic, Inc. announced that it was recalling its Sprint Fidelis defibrillation 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 Medtronic Defibrillator?

A defibrillator monitors heart rhythms. If it detects an unstable rhythm, it delivers an electric shock 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. A defibrillator consists of 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.”

What are Sprint Fidelis 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.

What is the Problem with Defective Leads?

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 lead fractures, 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.

How Do I Know If My Medtronic Leads are Defective and What Do I do?

There is no way to test for a lead fracture. 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 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 Medtronic 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.

If you or a loved one has been injured by a defective Medtronic defibrillator lead please contact us for a free consultation and case review. A Medtronic class action lead attorney can go over your legal rights and options and evaluate any potential claims you may have. You may be entitled to compensation and we can help.