The U.S. Food and Drug Administration (FDA) has issued an alert regarding certain Medtronic Kappa and Sigma Pacemakers stating that wiring problems in these devices defective medical could make them potentially lethal to patients. According to an article in Forbes magazine, the FDA, in this case, has classified the recall as Class I, which means that the continued use of these defective medical devices will cause serious adverse health consequences or death.
According to the alert, these defective medical devices may fail because of a separation of wires that connect the electronic circuit to other pacemaker components such as the battery. Patients with one of these defective pacemakers may experience a return of symptoms associated with abnormal heart rate including fainting or light headedness. In some cases, those patients dependent on these malfunctioning pacemakers may experience serious injuries or even death.
This defective medical device recall involves about 21,000 pacemakers, most of which have been implanted in patients for five years or longer. Worldwide, about 1.7 million Kappa or Sigma pacemakers have been implanted in patients. Medtronic Inc. apparently issued a letter to physicians cautioning them about this problem on May 18. Patients received the letter around the end of May. The recalled pacemakers include the Kappa Series 600/700/900 and the Sigma Series 100/200/300. Patients who have been implanted with these types of pacemakers should contact Medtronic to find out if their pacemakers are included in the current product recall.