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Health Sciences Authority
Dear Healthcare Professional Letters

Software update available for a subset of Azure™ S DR pacemakers to address incorrectly enabled Atrial Lead Position Check

Audiences

Healthcare professional

Industry member

Product type

Medical devices

4 June 2020

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 Ltd to inform healthcare professionals of the availability of a software update for a subset of Azure™ S DR pacemakers manufactured prior to February 2020 to address an issue in which the Atrial Lead Position Check (ALPC) was incorrectly enabled. ALPC is intended to operate as an optional feature in device models that offer atrial anti-tachy pacing therapies (ATP). Model Azure™ S DR does not offer atrial ATP and a subset of this device model has had this feature incorrectly enabled. This update will ensure that ALPC is inactivated in all Azure™ S DR devices. Device therapies and battery performance are not affected by this issue. No serious adverse events or patient harm have been reported. Currently, software updates are available for the programmers. Once a programmer is updated, the ALPC feature will be automatically inactivated at the patient’s next regularly scheduled interrogation if the device is affected. Healthcare professionals are advised that there is no need to schedule patients to come in outside of their planned, scheduled visits 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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