Implantable Cardioverter-Defibrillators Recalled

(Minneapolis, MN, USA). The Class I recall involves the Micro Jewel (model 7223Cx) and the Gem DR (Model 7271).

The company recently 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, and says the Gem model may take a longer-than-normal time to charge before delivering therapy. Most of these devices are close to the normal replacement time. No other devices of Medtronic are involved in the recall. A total of 6,268 of the affected ICDs were manufactured, and the company estimates that about 1,800 are still implanted in patients worldwide.

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 on whether or not to replace a device is based on the doctor's medical judgment and specific patient needs, says the company.

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 nondelivery of shock therapy. Such a delay or nondelivery could result in patient injury or death because patients are not receiving the appropriate therapy in time. Medtronic no longer uses this capacitor technology.

The company is working with the U.S. Food and Drug Administration to ensure that all doctors and their patients with these devices are notified of the issue. The FDA defines a Class 1 recall as a situation in which there is a reasonable probability that the use of he product will cause serious adverse health consequences or death.




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