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Feb 16, 2000 - 01:30 PM

St. Jude Warns Doctors of Possible Pacemaker Problem The Associated Press

LITTLE CANADA, Minn. (AP) - St. Jude Medical Inc. has informed doctors that a small number of its Affinity model pacemakers could malfunction and stop emitting the electrical signal that regulates a patient's heartbeat.

St. Jude said 33 of the its 35,000 Affinity pacemakers have been reported having problems, though the company is unaware of any patient injuries, spokesman Peter Gove said Wednesday.

Of the 891 pacemakers - 640 in the United States - that St. Jude has identified as potentially having the problem, the company believes about 90 are affected, said Gove.

That leaves about 60 pacemakers that may exhibit the problem within the next two years, he added.

"For the vast majority of patients, all their doctor will do is continue to monitor them. If the problem presents itself, they will then decide whether to replace the pulse generator," Gove said.

The pacemaker is implanted in a pocket under the skin in the pectoral muscle. Gove said replacing the pulse generator typically is outpatient surgery. The company said it would pay up to $800 of any patient's unreimbursed medical expenses for any such surgery.

The U.S. Food and Drug Administration has been advised of St. Jude's letter to doctors, said Gove, adding that no recall order has been issued.

Pacemakers help patients with slow heartbeats - a condition known as bradycardia. Normally the condition is not life-threatening. However, a small number of patients are dependent on their pacemakers and could die if the device stops working.

St. Jude Medical is nation's second largest pacemaker manufacturer, behind Medtronic Inc. About 300,000 St. Jude pacemakers of all types are in use in the United States, Gove said.

-- Homer Beanfang (Bats@inbellfry.com), February 16, 2000

Answers

BTW, St. Jude also makes Ventritex pacers and defibrillators. Don't know if they're affected though.

Frank

-- Someone (ChimingIn@twocents.cam), February 17, 2000.