More study needed on faulty heart device, cardiologist says

by Martin Moylan, Minnesota Public Radio

ST. PAUL, Minn. — A prominent Minneapolis cardiologist says St. Jude Medical isn't doing enough to study how to treat patients whose implanted heart rhythm devices could fail due to faulty equipment.

The criticism stems from problems with a wire lead that connects a patient's heart to an implanted defibrillator that corrects an irregular heartbeat. Faulty wires can make a defibrillator fail.

In an article in the New England Journal of Medicine, Minneapolis Heart Institute cardiologist Robert Hauser said St. Jude is not conducting studies needed to guide treatment for the some 70,000 patients who still have the wires implanted in them.

Hauser wrote, "We have no scientifically valid information to guide us."

St. Jude stopped selling the Riata model leads in question in 2010 and notified physicians they should closely monitor patients with devices using the wires.

Officials at St. Jude have launched a 500-patient study to get more information about how often the wires fail and to help guide patient treatment.