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Medtronic Announces Voluntary Recall of Small Number of Older ICD Models

Apr 21, 2004 |

Medtronic, Inc. announced that it is voluntarily recalling two older models of implantable cardioverter defibrillator due to a defect.

The Class I recall involves a small subset of Micro Jewel® II Model 7223Cx and GEM® DR Model 7271 ICDs. These two devices may have a defective high voltage capacitor that may take longer than normal to charge near the end of the battery service life. This may cause a delay or a non- delivery of shock therapy, resulting in patient injury or death because patients are not receiving the appropriate therapy in time.

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. In a press release, Medtronic said the Micro Jewell II device is no longer on the market, and the GEM DR device has limited distribution.

Most of these devices, implanted in 1997 and 1998, are close to the normal replacement time. No other Medtronic devices are involved in this recall.

The FDA and Medtronic said they are notifying physicians that they should verify the charge time and battery voltage of each affected device. If any device demonstrates 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 experience 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.

Medtronic noted that it 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 FDA to ensure that all physicians and their patients with these devices are notified of the issue. Medtronic began notifying physicians on April 5.

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