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Health Sciences Authority
Dear Healthcare Professional Letters

Potential Longevity Estimator Error of Medtronic programmer and remote monitoring software applications for a subset of implanted cardiac device models

Audiences

Healthcare professional

Product type

Medical devices

22 October 2019

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 potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. When the drop in estimated projected longevity is seen by a clinician, this could cause confusion regarding the battery performance. Software updates to programmers and remote monitoring systems are under development to correct for the inaccuracy in longevity estimates. In the meantime, healthcare professionals are advised to continue normal patient follow-up in accordance with standard practice and use the Recommended Replacement Time (RRT) notification (but do not use the longevity estimates) to identify when device replacement should be scheduled as per labelling. Where available, utilise the low battery voltage RRT audible alert or wireless CareAlert™. Additionally, if a lower-than-expected remaining longevity estimate occurs, Medtronic Technical Services can be contacted to assess if the decreased longevity estimate is due to this issue. 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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