Identity SR model 5172, Identity DR model 5370 and Identity XL DR model 5376 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2006/065

CON2025297

2006-11-23

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2025297

Potential for inaccurate display of: battery voltage expected battery longevity elective replacement indicator (eri) status at initial programmer interrogation. st jude medical has advised mhra that a programmer software anomaly can occur when the above programmers and pacemakers are used together. the manufacturer notified their uk customers of this issue in a letter dated 12 october 2006 (see appendix). the problem, which has only affected 53 out of approximately 199,100 pacemakers, results in the display of inaccurate battery voltage, expected battery longevity, and eri status. the anomaly does not affect the pacemaker's actual battery voltage, longevity or functionality. display of inaccurate data only occurs at initial programmer interrogation. correct battery voltage measurements and longevity status etc. will only be displayed when a manual measured data reading is performed. the anomaly is the result of a software interaction where a memory location within the pacemaker changes state. when this occurs, the data read on initial interrogation (from the pacemaker's memory) is not up to date. this affects the calculations for battery voltage, remaining longevity, eri status and magnet rate and therefore the displayed information is incorrect. in addition, as pacemakers approach the elective replacement time, this could result in the reporting of inappropriately high battery voltage and remaining longevity and could result in a delay in indicating eri status. to correct this problem, st jude medical has developed a software upgrade which, when installed on the programmer, will automatically correct an affected pacemaker memory location and ensure accurate battery status information is displayed. st jude medical advises that this will take place on first pacemaker interrogation following programmer software upgrade and will not extend the time needed for the appointment. st jude medical plans to release the upgraded software in december 2006 and anticipates that all potentially affected programmers in the uk will receive the software upgrade by the end of january 2007. st jude medical has already communicated this information to all uk hospitals that have received potentially affected pacemakers and programmers. neither st jude medical nor mhra have received any reports of adverse clinical events associated with this issue.

See detailed actions for patient management on page 3. For patients with pacemakers within two years of the longevity published in the pacemaker manual, perform a patient follow-up as soon as practically possible, giving priority to pacing dependent patients. For patients with pacemakers not within two years of published longevity, perform follow-up at the scheduled intervals. If you already routinely perform a manual measured data reading during follow-up, there is no need for any action.