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Health Sciences Authority
Dear Healthcare Professional Letters

Software update to address Unipolar Longevity Estimation Error of Medtronic programmer and remote monitoring software applications for affected cardiac devices

Audiences

Healthcare professional

Industry member

Product type

Medical devices

12 April 2021

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of the availability of software updates to address a potential longevity estimation error that may occur with the Medtronic programmer and remote monitoring software applications for a subset of implanted cardiac device models. An overestimation of the remaining longevity may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead due to the incorrect use of the bipolar lead impedance as input by the estimator algorithm (instead of the appropriate unipolar pacing lead impedance). If the software update is not applied to the programmer, confusion regarding device longevity could lead to a missed recommended replacement time (RRT) alert and potential delayed intervention. The longevity estimates for devices programmed to bipolar pacing in both the RA and RV chambers are not affected by this issue. Healthcare professionals are advised that no change in patient management is necessary as the corrective fix for this error is implemented in programmers and the CareLink network and the implanted devices do not need to be updated. For software updates in the healthcare professionals’ accounts, a Medtronic Representative or authorized personnel will assist with the software update installation. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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