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. That leaves about 60 pacemakers that may exhibit the problem within the next two years, he added. 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 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. About 300,000 St. Jude pacemakers of all types are in use in the United States, Gove said.