Medtronic Issues Physician Advisory Regarding Limited Subset of Pacemakers.

MINNEAPOLIS -- Medtronic, Inc. (NYSE:MDT) today said it is advising physicians that it has determined that a potential separation of interconnect wires from the hybrid circuit may affect a small subset of Sigma(R) series pacemakers.

Although the overall incidence rate is extremely low and there have been no reported patient injuries or deaths related to this issue, Medtronic is taking a conservative approach in advising the medical community and regulatory agencies. The anomaly may present clinically as loss of rate response, premature battery depletion, loss of telemetry or no pacing output.

Medtronic has observed an interconnect wire separation in 19 devices, an incidence of approximately 0.05 percent, in the affected subset of Sigma pacemakers. The estimated incidence of the anomaly for the affected devices is 0.17 to 0.30 percent over the ten-year projected life of the devices. Approximately 28,000 Sigma pacemakers are subject to the advisory worldwide, of which approximately 6,650 are in the United States.

"The risk to patients is extremely low, but we are alerting physicians to the issue to ensure they are aware of the situation and can appropriately care for their patients," said Steve Mahle, president of Medtronic Cardiac Rhythm Management. "While we know that each patient is unique, we do not recommend replacement of these devices prior to normal elective replacement. Patient safety has and will always be our primary concern, and we encourage patients to consult with their physicians on the proper course of action for their individual situation."

"The incidence rate for this issue is very low, but Medtronic is taking prudent action to ensure that physicians and patients have the information they need to make proper treatment decisions," said Dr. Kevin Wheelan, Director of Pacing and Electrophysiology & Co-Chief of the Department of Cardiology, Baylor University Medical Center (Dallas, Texas), a member of the independent panel of physicians who reviewed the issue for Medtronic.

Medtronic has communicated this information to regulatory authorities and is notifying physicians and hospitals of this action. The U.S. Food and Drug Administration (FDA) may classify this communication action as a recall.

Medtronic does not anticipate any material financial impact as a result of this notification.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 29, 2005. Actual results may differ materially from anticipated results.