FDA Calls Class I Recall on Some Medtronic Kappa, Sigma Pacemakers


June 11, 2009

June 11, 2009 - Medtronic Inc. yesterday said the FDA has classified Medtronic’s previously announced physician advisory about a small subset of Kappa and Sigma series pacemakers, identified at increased susceptibility for separation of bonded interconnect wires from the electronic circuit, as a class I recall.

Notification to FDA, physicians and patients began May 18. As of the date of this news release, more than 95 percent of physicians following affected devices in the U.S. have confirmed receipt of the notification. The FDA’s classification of Medtronic’s Important patient safety Information does not alter the patient management recommendations already provided in the May 2009 letter, and physicians need not take any new action.

Not all Medtronic Kappa and Sigma pacemakers are included in the advisory. Medtronic’s May 2009 communication to physicians involves a small subset of approximately 2 percent of the 1.7 million Kappa and Sigma pacemakers implanted worldwide since 1997. Medtronic has identified an increased susceptibility for separated interconnect wires in a specific subgroup of 10,000 of these devices in the U.S. that remain in patients. Most of the devices in the potentially affected subset have been implanted for five years or longer and may be nearing normal elective replacement time, Medtronic said.

In this limited subset of Kappa and Sigma series pacemakers, the issue can lead to loss of rate response, premature battery depletion, loss of telemetry, or no output, potentially causing patient symptoms such as fainting and lightheadedness, Medtronic said. Patients who experience these symptoms are reminded to seek medical attention immediately.

Patients can determine if their device is included in the identified subset by entering their device serial number at www.KappaSigmaSNList.medtronic.com. Patients whose serial numbers match any of those found on the Web site should contact their physician to determine an appropriate course of action. Patients without Internet access, or who have these models of devices but are unsure if their devices are included in this advisory may also contact Medtronic Patient Services at (800) 551-5544.

After consultation with the company’s Independent Physician Quality Panel, Medtronic’s May 2009 letter recommended that physicians consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets. Physicians should continue routine follow up in accordance with standard practice for those patients who are not pacemaker dependent.

For more information: www.medtronic.com