What is a defibrillator?
Why has Guidant recalled several of their heart defibrillators?
When is it used?
How does it work?
What will it accomplish?
What are the risks?
What models of Guidant defibrillators have been recalled?
What about Electromagnetic Interference?
When should it not be used?
How do I know if my defibrillator is malfunctioning?
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.

• Learn more about the Defibrillator Recall

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.

• Learn More About How Defibrillators Work

What will it accomplish?
ICDs protect against sudden cardiac death from ventricular tachycardia and ventricular fibrillation.


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

• Learn more about the FDA Defibrillator Recall

 
What about Electromagnetic Interference?
Some devices in your surroundings may interfere with your ICD. You may need to avoid certain types of security devices. Always carry your wallet ID card with you.

Household devices and appliances may affect your ICD. Ask your doctor which devices to avoid.

Some medical equipment can damage your ICD. If you are visiting your doctor or dentist, tell him or her that you have an ICD BEFORE they do any testing or treatment.

Some security devices may affect your ICD. A general rule of thumb is “Don’t lean, don’t linger” when moving through these devices.

Welders and electric generators may affect your ICD.


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.
 

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.

Why should I contact a lawyer?
With the recall of certain Guidant defibrillators, there is some evidence that Guidant Corp. may have known of the faulty devices for some time prior to alerting the FDA, doctors, and patients. Negligently designed and manufactured medical devices place patients at risk and can have serious, life-threatening, effects. If you have one of these recalled heart defibrillators, and have suffered due to their malfunction, you may have a legal claim against the manufacturer.

Only a qualified lawyer can help you determine your legal rights. Our nationally recognized firm includes a board-certified obstetric/gynecologist M.D., nurse/attorneys (R.N./J.D.'s), and nurse/paralegals including a former labor and delivery room nurse. In addition to our medical expertise, as seasoned litigators, the Medlaw Legal Team of Janet, Jenner & Suggs, LLC has expanded the rights of the injured by changing laws at the appellate and legislative levels.

We encourage you to contact our lawyers today for an immediate free claim evaluation. You may be eligible to participate in a class action lawsuit on behalf of patients who have been injured, or who have died, due to the serious malfunction of Guidant ICDs. Call 1-888-4-MEDLAW or complete our online claim evaluation form.