Medtronic Inc. is issuing a Class I recall for certain Medtronic Kappa and Sigma pacemakers because of wiring issues that may cause the devices to fail. A Class I recall is the Food & Drug Administration’s (FDA) most serious recall action, and is issued when there is a reasonable probability that the use of the device will cause serious adverse health consequences or death.
The Medtronic pacemakers involved in this recall include:
Kappa Series 600/700/900
Sigma Series 100/200/300
According to the FDA, the recall affects around 21,000 of the more than 1.7 million Kappa or Sigma pacemakers implanted in patients worldwide. Most of the devices affected by the recall have been implanted in patients five years or longer.
On May 18, 2009, Medtronic Inc. issued a letter to physicians, alerting them to the problem. The company followed up with a patient letter on May 27, 2009. At that time, the company warned that the devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. In the May 18 letter to doctors, Medtronic said it had received reports of two patient deaths where it is possible, but unclear whether a wire separation issue may have been a factor.
Patients with malfunctioning pacemakers 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.
The FDA is recommending that patients with the cited models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 1-800-505-4636 or going to the firm’s Web site. Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.