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 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 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.