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Heart Device Recalled

Older-Model Medtronic Implanted Defibrillators May Fail

From the WebMD Archives

April 21, 2004 -- Medtronic Inc., in cooperation with the FDA, is recalling some of its older-model implantable cardioverter defibrillators (ICDs).

ICDs are implanted in the chests of people whose hearts are at risk of developing a deadly heart rhythm. When ICDs detect this abnormal heart rhythm, they emit an electric pulse that is supposed to shock the heart back into normal rhythm.

The recalled devices have a defective high-voltage capacitor. This may make them fail to charge properly. If this happens, the device may not emit the proper shock. Medtronic reports that there have been four deaths and one serious injury caused by the failure of these devices.

The models in question are some of Medtronic's Micro Jewel II Model 7223Cx and GEM DR Model 7271 ICDs. Patients who have Medtronic ICDs with these model numbers should call their doctors immediately.

Medtronic no longer makes the Micro Jewell II device. The GEM DR device had only limited distribution. All of the ICDs in question were implanted in 1997 and 1998. They are nearing their normal replacement time. Of the 6,268 devices manufactured, some 1,800 are still thought to be implanted in patients worldwide.

Doctors are advised to check the devices' charge times. If they aren't working properly, Medtronic recommends replacement. However, the final decision on whether to replace the devices is based on each doctor's medical judgment and upon the needs of each patient.

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Sources

SOURCES: FDA. News release, Medtronic Inc.
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