FDA Classifies Previously Announced Medtronic Physician Advisory on Small Subset of Kappa and Sigma Pacemakers as Class I Recall

MINNEAPOLIS--(Business Wire)--
Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug
Administration (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 U.S. FDA, physicians
and patients began May 18, 2009. As of the date of this news release, more than
95 percent of physicians following affected devices in the United States 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.

It is important to note that 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.

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. 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 should 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.

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 25, 2008. Actual results may differ materially from anticipated results.

Medtronic, Inc.
Public Relations:
Christopher Garland, 763-526-1621
or
Investor Relations:
Jeff Warren, 763-505-2696

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