FDA NEWS RELEASE

For Immediate Release: June 11, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Alerts Patients to Medtronic Pacemaker Recall

-FDA News

06/11/2009 - The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma 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 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.

There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. Of those, only about 21,000 pacemakers are affected by this recall, most of which have been implanted in patients for five years or longer.

Medtronic Inc. issued a letter to physicians alerting them to this problem on May 18. The company communicated with patients via letter on May 27. 

The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Patients with these models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 800-505-4636 or going to their Web site at http://www.KappaSigmaSNList.medtronic.com.

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.

Through standard medical device reporting requirements, the FDA became aware of possible problems and worked with the company to address them. The FDA classified this voluntary recall as Class I, indicating reasonable probability that the use of the device will cause serious adverse health consequences or death.
For more information: 
Consumer article

If you or a loved one have been injured as a result of defective Medtronic pacemaker with wire seperation, Medtronic defective battery, or had the device replaced or plan to have it replaced you may be entitled to compensation regardless if you suffered as a result of complications from surgery or the device itself. Contact the Medtronic attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and Medtronic lawyers are standing by to answer any questions you may have regarding the Medtronic pacemaker defects, a possible Medtronic class action lawsuit, or any other type of Medtronic Pacemaker litigation. Call our Medtronic lawyer toll-free at: 1-800-856-6405 or fill out or free Defective Medtronic Pacemaker Lawsuit case evaluation form today.