Florida Guidant/Medtronic Defibrillator Lawyers

FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators

FDA is notifying health care providers and patients that the Guidant Corporation is recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed. The devices affected by this notification are:

• PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
• CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
• CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004

The devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver an electrical shock to the heart to restore normal heart rhythm. The PRIZM 2 and RENEWAL devices are subject to different failures, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia -- which could lead to a serious, life-threatening event for a patient. There have been two deaths reported to FDA suspected to be associated with this malfunction.

"The FDA's first priority is patient safety," said Daniel Schultz, MD, Director of FDA's Center for Devices and Radiological Health. "We want to ensure that all patients who may be affected by this problem are notified and seek appropriate medical advice from their physicians. "FDA is not making a recommendation on whether individual patients who have one of the Guidant devices should have it removed and replaced. This is a decision that should be made by a patient in consultation with his or her physician, based on the specific medical situation of the patient. Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision. The FDA advises patients to take the following steps:

• 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.

Guidant also recently informed FDA that it is recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance. Currently, FDA is evaluating this information.

Medtronic Announces a Nationwide, Voluntarily Recall of Small Subset of Two Implantable Cardioverter-Defibrillator Models

MINNEAPOLIS, April 16, 2004 - Medtronic, Inc. today announced that it is voluntarily recalling two older models of implantable cardioverter-defibrillators (ICDs). The Class I recall involves a small subset of Micro Jewel® II Model 7223Cx and GEM® DR Model 7271 ICDs that may take a longer than normal time to charge before delivering therapy. Most of these devices, implanted in 1997 and 1998, are close to the normal replacement time. No other Medtronic devices are involved in this action.

The Micro Jewel II device is no longer sold, and the GEM DR device has limited distribution. Physicians are being notified that they should verify the charge time and battery voltage of each affected device. If any devices exhibit unsatisfactory charge times, Medtronic recommends scheduling ICD replacement. The final decision whether to replace the device is based on the physician's medical judgment and specific patient needs.

Implantable cardioverter-defibrillators are medical devices used to shock the heart into normal rhythm after patients suffer ventricular tachycardia or fibrillation, which are rapid, life-threatening arrhythmias originating in the lower chambers of the heart. The devices are surgically implanted in the chest in a minor procedure lasting less than one hour.

When a cardiac arrhythmia requiring cardioversion or defibrillation shock occurs, the capacitor is normally charged, and the device delivers the appropriate shock. With the cardioverter-defibrillators in this recall, the capacitors may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or a non-delivery of shock therapy. Such a delay or non-delivery could result in patient injury or death because patients are not receiving the appropriate therapy in time. Medtronic no longer uses this capacitor technology.

Recently, Medtronic became aware of one serious injury and four deaths that may be related to the failure of the capacitor in a small subset of Micro Jewel II devices. A total of 6,268 of the affected ICDs were manufactured, of which about 1,800 are thought to be still implanted in patients worldwide. Medtronic is working with the U.S. Food and Drug Administration (FDA) to ensure that all physicians and their patients with these devices are notified of the issue. Medtronic began notifying physicians on April 5.

The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease.

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