Notification of a subset of Medtronic LINQ II™ ICM Systems (LNQ22) with potential issue for amplified noise and/or overall signal reduction

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to notify healthcare professionals about a population of LINQ IITM insertable cardiac monitors (ICM) which underwent a manufacturing process that may allow for moisture to impact electrode performance. This may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. As of 25 August 2023, there have been no reports of serious harm due to this issue. This notification provides instructions on the recall of the unused affected devices and patient management recommendations for existing users of the affected devices. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

20 Nov 2023

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

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.