All Press Releases for May 30, 2008

Medtronic Implantable Defibrillator

Medtronic has been a pioneer in the making of heart implant devices and is currently the nation's largest manufacturer.

    /24-7PressRelease/ - Golden, CO, May 30, 2008 - Medtronic has been a pioneer in the making of heart implant devices and is currently the nation's largest manufacturer. One of its products is an implantable defibrillator called the Sprint Fidelis and in October, 2007, Medtronic announced that it was withdrawing this device. A defect had been found in an electrical lead.

How the Heart Beats
The heart has four chambers, two above called atria and two below called ventricles. The atria receive blood returning from the lungs and carrying a fresh supply of oxygen. A heart beat is actually two beats, where first the atria beat in unison, sending blood through small valves into the ventricles, and then the ventricles beat to pump it out into the arteries.

The heart is instructed to beat by the brain, which sends electrical signals through the nervous system. A normal heart beats in a regular rhythm within a range of speeds. This pumps blood effectively throughout the body, to provide oxygen to all tissues and to collect up the carbon dioxide waste for disposal through the lungs.

When the heart's electrical system is somehow disturbed or impaired, the heart may speed up and flutter ineffectively, failing to pump blood out through the arteries. One such rhythm is called ventricular tachycardia and another is ventricular fibrillation. These arrhythmias must be corrected very quickly to save the person's life. Another one is called atrial fibrillation, and it is not such an emergency.

What is a defibrillator?
As the name suggests, it is a device to bring a heart out of fibrillation, but it can also correct other arrhythmias. Floor model defibrillators are used in hospitals, in cardiac units, and during those incidents known as "Code Blue", when a patient suddenly goes into a life-threatening heart rhythm.

An implantable defibrillator is a system with three parts:
• The defibrillator itself, consisting of electronics and a battery in a small case
• Leads (wires with electrodes) attached to it which are threaded through veins running to the heart
• The programmer, which is in a hospital or medical center, and used by a doctor or nurse to examine data sent to it.

The heart doctor who implants the defibrillator will custom-program it for each patient, to detect arrhythmias. When a malfunction occurs in the person's heart rhythm, the defibrillator will deliver a shock to the heart to bring it back to a normal rhythm, and send data about this incident to the programmer. The doctor can then analyze this information and determine what to do next.

Fibrillation will often render a person unconscious, but if the person is conscious, they feel the shock as a sudden impact to the chest. The heart may then go into a rhythm which is too slow (called bradycardia) - so most defibrillators can send pacing pulses to correct that and re-establish a normal rhythm. (A pacemaker is another implantable device -- it corrects heart rhythms that are too slow rather than too fast.)

The Medtronic Defibrillator Problem
In February, 2005, a defect was found in the electrode wire of about 87,000 implantable defibrillators named Sprint Fidelis. The wire (lead) was found to be liable to break which would cause the device to malfunction. It might then deliver unnecessary shocks to the person's heart, or fail to deliver one when it was needed because the battery had been depleted.

These Sprint Fidelis models have been used since 2004 and are implanted in over 250,000 patients. Medtronic immediately announced the problem and advised all such patients to contact their doctors.

When these leads were first on the market, they were a technological advance, as they were only 2.2 mm wide - about half the width of leads previously used. This made them easier to thread through veins. But they were new and had no history of safety.

Part of the problem is the difficulty of removing wires once the device has been implanted. They are threaded through veins, and the body builds up a layer of tissue around them inside that vein. So removal of the lead could damage the vein and cause undue bleeding. One possibility is to simply insert a second lead through the same vein.

Medtronic Lawsuits
There have been at least five deaths connected with defective leads and over 660 reports of malfunctions or injuries. Many defective product attorneys are preparing lawsuits, or have filed them, and Medtronic is facing potentially very large payment amounts.

If you have a Sprint Fidelis lead with your implanted defibrillator (your wallet card will give the model number), consult with your doctor immediately. If you have had no problems so far, you may not have any. Or your doctor may be able to reprogram the device and make it more able to detect a fracture in the lead, which information would show up in the programmer and be visible to the doctor.

Investigation into this whole matter is ongoing, but three things are clear at this point:
1. Medtronic should not have put these leads on the market, as there was insufficient safety data
2. Medtronic should have recalled them more quickly
3. Medtronic, like all manufacturers of medical devices, come under the legal theory known as strict liability, which makes it incumbent on them to provide safe products.

Class action suits are in the making. If you would like to know more about them, and about what it would mean for you as a person with a Sprint Fidelis lead implanted, the first step would be to arrange a free consultation with a defective product attorney.

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Patricia Woloch
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Golden, CO
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