On June 11, 2009, the U.S. Food and Drug Administration (FDA) alerted patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. The recalled devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.
The recall affects only 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.The affected pacemakers are:
- Kappa Series 600/700/900
- Sigma Series 100/200/300
A Class I recall indicates reasonable probability that the use of the device will cause adverse health consequences or death.
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.
have these recalled pacemakers and those who are unsure if their
pacemakers are affected should follow up with their primary care
physician or cardiologist.
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. Through standard medical device reporting requirements, FDA
became aware of possible problems and worked with the company to
address them. 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.