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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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

Contact:
Medtronic, Inc.
(800) 328-2518

FOR IMMEDIATE RELEASE -- 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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