Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) has issued an alert to patients just two weeks after Medtronic, Inc. sent separate letters to health care professionals and patients worldwide warning that thousands of its pacemakers could have faulty wiring that can cause the medical devices to work improperly or not work at all. This defect could have potentially deadly consequences for patients with the devices.

The Class I recall involves nearly 37,000 of Medtronic’s Sigma and Kappa pacemakers, most manufactured between November 2000 and November 2002. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that the device will cause serious adverse injury or death.

An estimated 15,200 active Kappa devices and 6,100 active Sigma devices are affected by the recall. Many of the devices have been implanted in patients for five years or longer and may be nearing what Medtronic calls normal elective replacement time. Of the active Kappa and Sigma devices, Medtronic has observed 285 Kappa devices and 131 Sigma devices with the failure mechanism.

Patients with a malfunctioning pacemaker may experience a return of symptoms associated with abnormal heart rate such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death, according to the FDA’s recall notice. Patients with questions about their pacemaker should contact their primary care physician or cardiologist, who can help identify if the patient’s medical device is included in the recall.

Source: FDA

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