Approximately 21,000 Kappa and Sigma pacemakers have been recalled by the FDA due to a wiring defect that could cause a severe heart injury or death.

Medtronic first notified physicians and patients of the pacemaker defects in May, reporting that there had been at least two fatalities potentially connected with the wiring. The FDA has now classified the action as a “Class I” recall, which indicates that the product carries a reasonable probability of adverse health consequences of death.

While the recall only applies to about 21,000 of the more than 1.7 million Kappa or Sigma pacemakers implanted throughout the world, approximately 15,200 patients with Medtronic Kappa pacemakers installed for five years or longer and another 6,100 patients with Medronic Sigma pacemakers installed for more than five years are included in the recall. Medtronic Kappa Series 600/700/900 pacemakers and Sigma Series 100/200/300 pacemakers could be affected by this latest recall. These devices were manufactured primarily between November 2000 and November 2002.

According to a letter sent to healthcare professionals on May 18, 2009, Medtronic did not recommend that physicians consider replacing the device unless a patient is pacemaker dependent or a device is already at the elective replacment time.

Patients experiencing problems with a defective pacemaker may show signs of lightheadedness and fainting, and should contact their doctor if these signs occur.

Hundreds of deaths and thousands of injuries can be traced to defective medical devices each year.

This entry was posted on Thursday, June 18th, 2009 at 3:33 pm and is filed under Medical Device. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.