A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) reported that it has distributed a programmer software upgrade to eliminate a random, low-frequency anomaly that could impact ventricular sensing in the Epic and Atlas families of implantable cardiac defibrillators.

Specifically, it said that 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 about 143,000 implanted since July 2002) has been found to exhibit a loss of ventricular sensing, the company said.

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 non-invasive software upgrade can be completed in approximately 10 to 20 seconds, during which time the device will maintain full function.

St. Jude develops therapies for cardiac, neurological and chronic pain patients.