St. Jude Tells Doctors of Software Problem in Some DefibrillatorsJun 21, 2005 | Star Tribune
St. Jude Medical Inc. has notified doctors and federal regulators of a software problem in some models of its implantable defibrillators that could cause the heart-shocking device to malfunction.
About 39,000 patients are affected by the news, although the company said no deaths or injuries have occurred as a result.
The Little Canada-based medical technology company said some models of its Atlas and Epic implantable defibrillator, or ICD, need a brief, noninvasive upgrade that can be done during an office checkup.
The news comes as rival Guidant Corp., whose cardiac rhythm management division is based in Arden Hills, deals with the fallout from a recall of 50,000 of its ICDs last week. And, earlier this year, Fridley-based Medtronic recalled 87,000 ICDs that had a battery depletion problem.
ICDs are implanted devices the size of a stopwatch that are placed in the upper chest and shock or pace an errantly beating heart back into rhythm.
St. Jude said it discovered the two "anomalies" during a routine product evaluation. They include:
• In ICDs past their mid-life, a series of shocks might be skipped as the device delivers its routine of multiple shocks to revitalize the patient's heart. The first shock would be delivered, but the device might deliver fewer than the maximum of six shocks per episode. The devices on average last four to seven years before replacement.
• A second problem could cause a temporary increase in the device's pacing rate. (In addition to its shocking therapy, some patients need an ICD that can pace their heart, as well.)
The company said the software upgrade was approved by the Food and Drug Administration on Friday.
St. Jude is providing doctors with a software tool to correct the programmer, a tabletop computer that permits noninvasive communication with the implanted device.
A wand is placed on the patient's chest and the computer will determine whether the ICD is among the affected lot. If so, new software will be downloaded to the device in a procedure the company said takes 45 seconds.
St. Jude said company representatives will install the corrective software.
The affected models include: Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-239T/V-196T/V-350), Atlas DR (V-242), and Atlas Plus DR/VR/HF (V-243/V-193/V-193C/V-340/V-341/V-343).