| Medtronic Issues Notification Regarding Certain Implantable Defibrillator Models February 11, 2005 -- Medtronic, Inc., (NYSE: MDT) today said it is voluntarily advising physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models. In a letter to physicians, Medtronic reported that nine batteries (0.01 percent or approximately 1 in 10,000) have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths.
Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Potentially affected models are the Marquis™ VR/DR and Maximo™ VR/DR ICDs and the InSync I/II/III Marquis™ and InSync III Protect™ CRT-D devices. Approximately 75 percent of these devices were implanted in the United States. Patients with other models of Medtronic devices or these device models with batteries manufactured after December 2003 are not affected.
As part of the company's program to analyze products returned from physicians, Medtronic identified nine of 87,000 implanted devices (0.01 percent) with a battery design that exhibited this shorting mechanism. Based on highly accelerated company testing, Medtronic estimates that this rate may increase up to between 0.2 percent and 1.5 percent over the second half of device life.
ICDs shock or pace the heart into normal rhythm after patients suffer rapid, life-threatening heart rhythm disturbances originating in the lower chambers of the heart that can lead to sudden cardiac arrest (SCA). CRT-Ds can also provide electrical pulses to the heart's two lower chambers to improve heart failure symptoms. An ICD or CRT-D device is surgically implanted in the chest in a procedure typically lasting one to two hours.
"We were able to identify this possible risk through our stringent product testing," said Steve Mahle, president of Medtronic Cardiac Rhythm Management. "Even though the potential for rapid battery depletion is extremely low, we see it as our obligation to alert all implanting physicians to the issue and provide ways to help them and their affected patients successfully manage the situation."
Medtronic began notifying physicians about the situation on Feb. 10, providing them with a list of potentially affected patients and recommending that physicians communicate with those patients and follow them closely. Medtronic is communicating this information so that physicians are aware of the potential issue and can manage it as they feel is appropriate with their individual patients.
Medtronic Announces a Nationwide, Voluntarily Recall of Small Subset of Two Implantable Cardioverter-Defibrillator Models April 16, 2004 - Medtronic, Inc. today announced that it is voluntarily recalling two older models of implantable cardioverter-defibrillators (ICDs). The Class I recall involves a small subset of Micro Jewel® II Model 7223Cx and GEM® DR Model 7271 ICDs that may take a longer than normal time to charge before delivering therapy. Most of these devices, implanted in 1997 and 1998, are close to the normal replacement time. No other Medtronic devices are involved in this action.
The Micro Jewel II device is no longer sold, and the GEM DR device has limited distribution. Physicians are being notified that they should verify the charge time and battery voltage of each affected device. If any devices exhibit unsatisfactory charge times, Medtronic recommends scheduling ICD replacement. The final decision whether to replace the device is based on the physician's medical judgment and specific patient needs.
Implantable cardioverter-defibrillators are medical devices used to shock the heart into normal rhythm after patients suffer ventricular tachycardia or fibrillation, which are rapid, life-threatening arrhythmias originating in the lower chambers of the heart. The devices are surgically implanted in the chest in a minor procedure lasting less than one hour.
When a cardiac arrhythmia requiring cardioversion or defibrillation shock occurs, the capacitor is normally charged, and the device delivers the appropriate shock. With the cardioverter-defibrillators in this recall, the capacitors may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or a non-delivery of shock therapy. Such a delay or non-delivery could result in patient injury or death because patients are not receiving the appropriate therapy in time. Medtronic no longer uses this capacitor technology.
Recently, Medtronic became aware of one serious injury and four deaths that may be related to the failure of the capacitor in a small subset of Micro Jewel II devices.
A total of 6,268 of the affected ICDs were manufactured, of which about 1,800 are thought to be still implanted in patients worldwide. Medtronic is working with the U.S. Food and Drug Administration (FDA) to ensure that all physicians and their patients with these devices are notified of the issue. Medtronic began notifying physicians on April 5.
The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
If you or a loved one received a Medtronic heart device, you may confidentially complete our online claim form. We will respond to your inquiry at no cost or obligation within one business day. | 
