Medtronic Defibrillator Leads

Sprint Fidelis defibrillator leads have been recalled due to risk of failure with potentially fatal consequences.

Defective Defibrillator Leads

Sprint Fidelis® defibrillator leads manufactured by Medtronic, Inc. have been recalled by Medtronic after it was discovered that the wires are subject to developing fractures or cracks that can lead to malfunction of the defibrillator device with potentially fatal consequences.  On October 15, 2007, Medtronic published a letter addressed to Medtronic Heart Device Patients disclosing problems with Sprint Fidelis defibrillation leads (Models 6930, 6931, 6948, 6949).

Defibrillator systems consist of a defibrillator device normally implanted near the patient's shoulder and thin wire leads that connect the device directly to the chambers of the heart.  The fractures which can occur in the thin wire leads can cause a distortion in the electrical signal that is carried from the heart to the defibrillator device by the lead.  When a lead 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. When the defibrillator system and leads function correctly, the system can be a lifesaver, restoring normal rhythm to the heartbeat.  When they malfunction, the result can be fatal.

According to FDA records, one patient death occurred in 2006 when the patient's defibrillator device delivered inappropriate shocks. The patient then developed various heart conditions and eventually died.  Also according to FDA records, at least one other patient has died after the defibrillator device failed to deliver a required shock when needed, apparently because of a problem with the lead.

Sprint Fidelis Leads with Defibrillators from Other Manufacturers

Patients should be aware that Sprint Fidelis leads may be implanted with defibrillator/pacemaker devices from manufacturers other than Medtronic. If you have reason to believe that you may have a Sprint Fidelis lead or if you do not know the model of your lead, you should contact your health care professional.

FDA & Medtronic Advise Against Removal

Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society recommend routine surgical removal of a fractured lead because removal carries additional risks.  Instead, they advise that 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 usable and implanting a different model.

Injured by Defective Medtronic Leads?

If you or a family member received a defective Medtronic defibrillator lead and have been injured by the device, you may be entitled to compensation from those responsible for the injury.  At Arnold & Itkin LLP, our attorneys have the knowledge and experience to take on large medical device manufacturers like Medtronics and hold them accountable for their actions.

For a free consultation with an experienced attorney, contact a medical injury attorney online or phone Arnold & Itkin LLP toll free at 1-866-222-2606.

 

Medtronic Sprint Fidelis Leads Questions & Answers

(Source: FDA.gov)

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.

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/fidelis/

More information about Defective Medtronic Defibrillator Leads

F.D.A. Tests on Devices Scrutinized

NYTimes.com - October 23, 2007

Statement on Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads

FDA.gov – October 15, 2007

Medtronic withdraws leads for heart devices

USAToday.com – October 16, 2007

Patients Warned as Maker Halts Sale of Heart Implant Part

NYTimes.com – October 15, 2007

Medtronic Defibrillator Patients: Information on Sprint Fidelis Defibrillator Lead

Medtronic.com

 

Sprint Fidelis® is a registered trademark of Medtronic, Inc.

 

 

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