Medtronic Fidelis Lead Recall News | ICD Failure Defibrillator Problems Information

Sprint Fidelis leads are manufactured by Medtronic, the medical device manufacturer headquartered in Minnesota. The Medtronic Fidelis lead consists of cardiac electrodes which are thin wires. These electrodes connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart.

The Medtronic Fidelis leads recall was announced by the manufacturer and the FDA due to the potential for lead fractures or ICD failure. Following reports of fractured leads and at least 5 patient deaths caused by defibrillator problems, Medtronic recalled their Sprint Fidelis defibrillator leads. Patients may be at an increased risk of having their leads fracture or break. If this happens the defibrillator could deliver painful shocks or jolts or fail to operate at all.

Overview of ICD defibrillator/leads

For life-threatening cardiac arrhythmias that include ventricular fibrillation (chaotic heartbeat) and ventricular tachycardia (dangerously fast heartbeat), defibrillation is the definitive treatment, consisting of delivering a therapeutic dose of electrical energy to the affected heart with a device called a defibrillator. This dose of energy depolarizes a critical mass of the heart muscle, terminating the arrhythmia and allowing normal sinus rhythm to be reestablished by the body’s natural pacemaker in the sinoatrial node of the heart.

Types of Defibrillators

Defibrillators can be external, transvenous, or implanted, depending on the type of device used or needed.

Manual external defibrillators are used in conjunction with electrocardiogram readers, which the healthcare provider uses to diagnose a cardiac condition. The healthcare provider will then decide what charge (in joules) to use, based on proven guidelines and experience, and will deliver the shock through paddles or pads on the patient’s chest. As they require detailed medical knowledge, these units are generally only found in hospitals and on some ambulances.

Automated external defibrillators (AEDs), automate the diagnosis of treatable rhythms, meaning that lay responders or bystanders are able to use them successfully with little, or in some cases, no training at all. These units are based on computer technology that is designed to analyze the heart rhythm itself and then advise the user whether a shock is required. They are usually limited in their interventions to delivering high joule shocks for ventricular fibrillation and ventricular tachycardia rhythms, making them generally limiting for use by health professionals who could diagnose and treat a wider range of problems with a manual or semi-automatic unit. The automatic units also take time (generally 10-20 seconds) to diagnose the rhythm, where a professional could diagnose and treat the condition far quicker with a manual unit.

An implantable cardioverter-defibrillator (ICD), also known as an automatic internal cardiac defibrillator (AICD), is a pager-sized device similar to a pacemaker (and many can also perform the pacemaking function). They constantly monitor the patient’s heart rhythm to detect and stop dangerous abnormal heartbeats (arrhythmias) by automatically administering electrical shocks to restore a normal heart rhythm when necessary. Many modern devices can distinguish between ventricular fibrillation, ventricular tachycardia, and more benign arrhythmias like supraventricular tachycardia and atrial fibrillation.
Implantable Cardioverter-defibrillator (ICD)

The procedure to implant an ICD is usually relatively minor and typically takes one to three hours. It can be performed with numbing medication and a sedative that puts you in a relaxed state but allows you to remain aware of your surroundings. During surgery, a flexible, insulated wire (lead) is inserted into a major vein under or near your collarbone and guided, with the help of X-ray images, to your heart. The ends of the leads are secured to your heart’s bottom pumping chambers (ventricles), while the other ends are attached to the shock generator, which is usually implanted under the skin beneath your collarbone.

After implantation, your doctor will test your ICD and program it to treat your specific heart rhythm problem. Testing requires shocking your heart, which will require general anesthesia so that you are not awake during the test, and you will need to stay in the hospital one or two days. The ICD may be evaluated one more time before you are discharged but any additional tests of your ICD usually do not require surgery.

An ICD is usually programmed to perform these functions:

• Cardioversion. If the ICD detects a dangerously fast heartbeat, it delivers an electrical shock that converts the fast heartbeat into a slower, normal heartbeat.
• Defibrillation. If cardioversion fails and your heartbeat either quickens or beats chaotically, or sometimes a chaotic heartbeat develops spontaneously, the ICD delivers a stronger electrical shock that resets (defibrillates) your heart to start beating normally.

An ICD can also be programmed to perform anti-tachycardia pacing, anti-bradycardia pacing, biventricular pacing or record heart activity.

You are a prime candidate for an ICD if you have had ventricular tachycardia, survived a cardiac arrest or have fainted from a ventricular arrhythmia. You may also benefit from an ICD if you have a history of coronary artery disease and prior heart attack that has led to a weak heart; a heart condition that involves abnormal heart muscle, such as enlarged (dilated cardiomyopathy) or thickened (hypertrophic cardiomyopathy) heart muscle; or you have an inherited heart defect that makes your heart beat abnormally.

We represent all Medtronic Fidelis lead 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 a Medtronic recall attorney will contact you to answer any of your questions.