Update! This issue has been resolved with new programmer software
released in December 2006. We are providing the information below as an archive
of the original announcement.
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Dear St. Jude Medical Patients:
St. Jude Medical Inc. announced on October 13, 2006, that it has discovered a low-frequency anomaly in software used in certain St. Jude Medical programmers.
In particular, when these tabletop programmers are used with certain models of Identity pacemakers, the anomaly in the programmer's software may lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator status. The Identity pacemakers are Models 5172, 5370, and 5376. No other St. Jude Medical device is affected.
The software anomaly does not affect the device's actual battery voltage, longevity or functionality and the Company has developed a software upgrade that fully remedies the issue. St. Jude Medical will release the upgrade as soon as pending regulatory approvals are obtained.
Read a full copy of the physician communication, which includes a description of the anomaly. Read the complete news release. Read the physician device advisory notice in accordance with recent recommendations from the Heart Rhythm Society Task Force on Device Performance, Policies and Guidelines. We apologize for any inconvenience to our patients as a result of the necessary software upgrade. Please contact your physician if you have specific questions regarding your device.