St. Jude Cardiac Defbrillator News

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June 21st, 2005

"World’s third largest implantable defibrillator company discovers flaws"

Days after Guidant Corp. recalled about 50,000 of its cardiac defibrillators because of reported failures resulting in at least two deaths, competitor St. Jude Medical Inc., the world’s third-largest maker of implantable defibrillators, said it discovered defects in its devices.

The company announced that patients with two of its heart devices need 45-second software upgrades to correct two defects. The company said it has already provided doctors with the software to correct the flaws in its Epic and Atlas implantable cardiac defibrillator models.

Defects were discovered during routine product evaluation, according to the company, and the flaws affect about 39,000 devices. One of the cardiac defibrillator defects can cause a two-second to four-second delay in shocking a patient’s heart back to normal rhythm. The second flaw can lead to a temporary increase in heart pacing rate.

After talking to the U.S. Food and Drug Administration, St. Jude decided to notify doctors about the cardiac defibrillator defects. The defect announcement was made after the U.S. stock markets closed Monday, June 20.