Over 20,000 "Kappa" and "Sigma" pacemakers manufactured by Medtronic, Inc. are being recalled because of a wiring problem that can cause the devices to fail, posing an obvious and very serious health problem for patients.
While more than 1.7 million Medtronic "Kappa" and "Sigma" pacemakers have been implanted in patients worldwide, the recall announced last Thursday affects about 21,000 of those devices: specifically, the Kappa Series 600/700/900 and the Sigma Series 100/200/300. The FDA says that most of the affected pacemakers have been implanted in patients for five years or more.
An FDA News Release details the problem with the Medtronic pacemakers: "These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Patients with malfunctioning pacemakers may experience symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death."
Patients who think they may be affected by the Medtronic pacemaker recall should contact their primary physician or cardiologist. According to the FDA, patients can also find out if their pacemaker is affected by contacting Medtronic at 800-505-4636 or visiting their web site at http://www.KappaSigmaSNList.medtronic.com.
The FDA has designated the Medtronic Kappa and Sigma pacemaker recall as "Class I," the agency's most serious recall classification. A Class I medical device recall signals a "reasonable probability that the use of the device will cause serious adverse health consequences or death," according to the FDA.
This isn't the first health risk associated with a Medtronic medical device. In October 2007, Medtronic issued a warning to patients and doctors that an electrical wire (called a "lead") manufactured by Sprint Fidelis and used in Medtronic defibrillators could fracture. And in 2005, Medtronic issued a warning on some of its implantable defibrillator models, because a potential battery shorting problem could occur. Learn more: Medtronic Defibrillator Overview.