Medical Device Correction for Reveal LINQ™ Insertable Cardiac Monitor model LNQ11
Healthcare professional
Medical devices
29 March 2016
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Medtronic International Ltd would like to notify healthcare professionals on the sensitivity of an algorithm used in the Reveal LINQ™ Insertable Cardiace Monitor (ICM) Model LNQ11 that may prematurely trigger the Recommended Replacement Time (RRT) alert. As of February 12, 2016, Medtronic has observed an occurrence rate of 0.45% of devices experiencing this issue. Battery capacity is not affected and the device will continue to support data collection and manual data transmission. Healthcare professionals are advised against prophylactic device replacement and to contact Medtronic for assistance with determining if an RRT alert is due to the algorithm sensitivity 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.
