DEFIBRILLATOR QUESTIONS & ANSWERS

• What is it?
• Why has Guidant recalled several of their heart defibrillators?
• When is it used?
• How does it work?
• How do I know if my defibrillator is malfunctioning?
• What are the risks?
• What models of Guidant defibrillators have been recalled?
• When should it not be used?
• Why should I contact a lawyer?

What is it?
An implantable cardioverter defibrillator (ICD) is a device that monitors heart rhythms, and delivers shocks if dangerous rhythms are detected. Many ICDs record the heart’s electrical patterns whenever an abnormal heart beat occurs. Doctors can review this record during regular check-ups to help plan future treatment options.

Why has Guidant recalled several of their heart defibrillators?
The recalls are linked to a potential flaw where some could short circuit and not work at all. So, at the very moment when the patient's life depends on the reliability of the ICD, the device can malfunction.

When is it used?
ICDs are used to treat patients whose lower heart chambers (ventricles) beat too quickly (tachycardia) or quiver ineffectively (fibrillation). They are also used in patients who are at risk of these conditions due to previous cardiac arrest, heart failure, or ineffective drug therapy for abnormal heart rhythms.

How does it work?
Like a pacemaker, an ICD consists of a battery and electrical circuitry (pulse generator) connected to one or more insulated wires. The pulse generator and batteries are sealed together and implanted under the skin, usually near the shoulder. The wires are threaded through blood vessels from the ICD to the heart muscle.

The ICD continuously checks the heart rate. When it detects a too-rapid or irregular heartbeat, it delivers a shock that resets the heart to a more normal rate and electrical pattern (cardioversion).

Stopping the potentially fatal fibrillation is called defibrillation.

How do I know if my defibrillator is malfunctioning?
There may not be any signs, but the FDA recommends:

• If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
• Continue to keep your regular doctor appointments.
• If you feel an electrical shock from your device, immediately contact your doctor.
• If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.

What are the risks?
Potential risks from the surgical procedure include infection, bleeding, and bruising. Other rare complications include stroke, heart attack, blood clots, or perforation of a major vessel, a lung, or the heart muscle.

Your doctor will tell you about additional risks from ICDs.

What models of Guidant defibrillators have been recalled?
As the Food and Drug Administration (FDA) continues to evaluate the safety and performance of certain implantable defibrillators manufactured by Guidant Corporation, the Agency has now classified the recalled devices.

Classifications can fall into three categories, with Class I being the most serious. These numerical classifications are based on the probability that the device failure could lead to adverse health effects.

PRIZM 2 DR, CONTAK RENEWAL, and CONTAK RENEWAL 2 Devices- Class I; VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT Devices- Class II; CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF Devices- Class II

When should it not be used?
ICDs should not be used in patients whose heart conditions are reversible or temporary. They should not be used in patients who will not benefit from the devices, or who are sensitive (allergic) to the exposed components.

Why should I contact a lawyer?
Brown & Crouppen’s twenty-five year reputation for success is based on the firm’s commitment to deliver the best possible service to clients while making a real difference in people’s lives. We have represented many victims injured by dangerous drugs, defective medical devices and unsafe implants. We have invested significant effort and resources to hold the manufacturers of hazardous products accountable for the promises they make and the promises they break. Our product liability claims have included prostheses, heart devices (pacemakers and valves), hip replacements and knee replacements.

At Brown & Crouppen our experienced team of lawyers provide tough, aggressive representation for victims and their families. When you choose us to handle your lawsuit, our entire team becomes fully committed to your cause. We’ll find answers, hold negligent companies responsible and get you the compensation you deserve.

Brown & Crouppen can help you make informed decisions about your legal rights, so please call Brown & Crouppen at 1-800-536-HELP for your free legal consultation or save time with our online Contact Form.