The programmers used to interrogate and program the St. Jude Medical bradycardia and tachycardia products all perform self-test routines upon power-on initialization sequences. The self test routines check the internal hardware and software and upon completion will provide the user an indication that the test was successful by displaying the "power-on" screen and giving the user access to interrogation. If any portion of the self-test routine fails, the programmer will display a message indicating the reason for the failure and disable the programmer from being used.

The SJM Confirm ICM is a cardiac rhythm diagnostic tool that collects valuable data regarding the patient's intrinsic rhythm. Diagnostics are collected via the sensing electrodes positioned on the case and therefore optimal site selection, device orientation, and proper programming are essential for reliable sensing. This Technical Insight provides some implant and programming techniques that will promote optimal device function.

St. Jude Medical does not provide field testing of potential sources of interference. A trained EMI testing consultant can perform an assessment of a patient's workplace environment. See the list of potential EMI test consultants.

Software upgrade available to resolve and eliminate a very rare occurrence that could lead to a ventricular sensing anomaly.

St. Jude Medical encourages, logs and tracks all verbal and written reports with respect to any device or lead issue. The performance of the Riata family of leads has been strong. Read this report for details.

This issue has been resolved with new programmer software released in December 2006. Read the archive of the original announcement.

St. Jude Medical will provide a Returned Products Kit to organizations and physicians who have explanted devices from patients.