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October 18, 2007

U-M Health System information on heart device recall

ANN ARBOR, MI – Some University of Michigan Health System pediatric and adult heart patients are affected by a recall that was announced by medical device manufacturer Medtronic and the U.S. Food and Drug Administration on October 15.

The recall is for a part called a “lead” within a type of implantable heart device that is used to regulate heart rhythm. The recall means that the devices will no longer be used in new patients, and that existing patients’ devices need to be checked.

The recall is taking place because the leads could malfunction and interrupt the ability of the device to control the pace of a patient’s heartbeat – or could cause a patient to get an unnecessary shock. Fortunately, only a small number of the recalled leads have been demonstrated to be defective.

At UMHS, the recall affects approximately 500 patients. About 450 of them are adults treated at the U-M Cardiovascular Center and University Hospital, and about 50 are children and teenagers treated at the Michigan Congenital Heart Center at C.S. Mott Children’s Hospital.  

This number represents about one in 10 of the more than 5,000 University of Michigan patients who currently have implanted cardiac devices. These devices are used to regulate heart rhythm in patients who are at risk of potentially life-threatening heart rhythm problems.

It is important to note that thousands of patients who have received implanted heart devices at U-M are not affected by the recall, because their device does not include the recalled part.

In accordance with recall recommendations, U-M is asking all patients whose devices include the recalled part to come in to have their device checked and possibly reprogrammed.

Patients can determine if their device includes the recalled part by referring to the wallet card they received when they had their device implanted.

If the card shows that they have Medtronic Sprint Fidelis leads with the model numbers 6930, 6931, 6948 or 6949, their device contains the recalled part and they should call U-M as soon as possible using the numbers below. If they cannot find their wallet card, they should also call U-M using the numbers below.

If a patient’s wallet card does not include these numbers, the patient is not affected by the recall.

Patients affected by the recall will be evaluated at specialized U-M device clinics to determine the most appropriate course of action. Options include reprogramming of the device’s computer, or a surgical procedure to replace the lead.

As soon as the recall was announced, U-M doctors and nurses began evaluating patient records and developing a plan for communication to patients whose devices include the recalled part. A letter will go out this week to all these patients, who will also be contacted by phone.

Additional U-M clinic appointments are being added so that patients can be seen at a time that’s convenient for them.

U-M doctors are following the situation with this recall very closely. If any new information becomes available that will change what we are recommending for specific patients, we will contact them immediately.

The U-M Cardiovascular Center and Michigan Congenital Heart Center offer two of the largest and most experienced programs in the nation for adults and children, respectively, who have heart rhythm disorders or high risk of potentially life-threatening heart rhythm disorders.

Phone numbers:

Adult U-M patients who are affected by this recall should call 734-647-7321.

Parents of children and teenagers who are U-M heart device patients affected by this recall should call 734-764-5176.

Medtronic has created a phone line for all patients with the recalled part, at 1-800-551-5544, ext. 41835. It is available from 8 a.m. to 10 p.m. ET.

Written by Kara Gavin

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