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St. Jude ICD Product Recall
In June 2005, St. Jude Medical issued a warning to doctors and medical professionals that some of its Implantable Cardioverter Defibrillators (ICD) may need software upgrades. Shortly after, the FDA announced a recall on the following product families after the discovery of 52 reported events in the FDA database related to St. Jude's Epic and Atlas products.
Of these 52 reported instances by consumers using the pacemaker-like devices, 10 are related to the "reset" mode which can result in the defibrillator function shutting off without warning. The reset mode can be triggered when simply exposed to intense electrical or magnetic activity. The FDA states that they are recalling the products for software upgrades due to the Skipped-Charge Shock and a Sensor Noise Anomaly.
Recalled St. Jude ICDs:
EPIC (Models V-233, V337, V-338)
EPIC PLUS DR/VR/HF (Models V-236, V-239, V-239T, V-196, V-196T, V-350)
ATLAS DR (Model V-242)
ATLAS PLUS DR/VR/HF(Models V-242, V-193, V-193C, V-340, V-341, V-343)
These pacemaker-like devices are used by patients with life-threatening heartbeat rhythm problems and are designed to provide cardiac resynchronization therapy to keep the heartbeat in steady rhythm. Many of these implanted devices were only recently approved by the FDA but have already been distributed to 30,000 U.S. patients and 11,684 international patients.
Patients who are using one of these recalled St. Jude ICDs should seek advice from their doctor to undergo the software upgrade process.
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Last updated on Aug-30-05