Thursday, October 12, 2006

New St. Jude Pacemaker Advisory

Tomorrow doctors will receive a "Dear Doctor" letter notifying them about a software problem with St. Jude Medical's Identity SR, Identity DR, and Identity XL DR pacemakers. This advisory was issued because of 53 reports or 0.027% (of 199,100 devices) where the patient's elective replacement indicator (ERI) measurement that was stored in the memory of the device was "frozen." This problem might lead the physician to think that acceptable battery voltage remained in the device. However, if a second, real-time measurement is performed, the ACTUAL battery voltage and longevity estimate will be correctly displayed.

Fortunately, the problem can be corrected with an injected software fix (no surgery required). The software, we are told, should be available in about two months. Patients with these devices should check with their doctor during their routine pacemaker checks to assure they receive the newest software installed on their device when it becomes available.


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