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News

St Jude Medical releases programmer software upgrade to eliminate low-frequency anomaly in defibrillators

St Jude Medical : 21 January, 2008  (New Product)
St Jude Medical has distributed a programmer software upgrade to eliminate a random, low-frequency anomaly that could affect ventricular sensing in the Epic and Atlas families of implantable cardiac defibrillators.
Specifically, a potential loss of ventricular sensing has been attributed to an extremely rare timing sequence that occurs in a very small (61 microsecond) timing window. To date, an incidence of 0.00006 of the subject device population (eight out of approximately 143,000 implanted since July 2002) has been found to exhibit a loss of ventricular sensing.

Although the company has not received any reports of adverse events or clinical complications associated with the anomaly and the rate of incidence is very low, the company has chosen to take a conservative and transparent approach in advising the medical community and regulatory agencies.

The new software will be downloaded into the device during a patient's next routine check up and will fully prevent the anomaly from occurring in the future. The simple, non-invasive software upgrade can be completed in approximately 10 to 20s, during which time the device will maintain full functionality. St Jude Medical, in consultation with its independent Medical Advisory Board members, has determined that no other action is recommended.

The company is in the process of distributing the programmer software to its physician customers.
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