ST. JUDE ANNOUNCES ICD SOFTWARE UPGRADE

St. Jude Medical has notified physicians that its Epic and Atlas implantable cardioverter defibrillator (ICD) models are in need of a non-invasive, 45-second software upgrade to correct two anomalies found during routine product evaluation.

The two issues are: for a charging cycle to be skipped as the device attempts to deliver multiple shocks in rapid succession when a device's battery voltage is past mid-life and approaching its elective replacement indicator; and an electrical "noise" generated as a result of the charging of the device's high-voltage capacitors.

The anomalies do not pose a significant risk to patients, and the company has not received any reports of patient adverse events or clinical complications as a result of the anomalies. In addition to notifying its customers, St. Jude provided physicians with a simple software tool to correct the issues via its programmer. The upgrade should be done at the patient's next routine follow-up visit or at the physician's discretion.