Notification on additional subset of Medtronic LINQ II™ Insertable Cardiac Monitoring Systems with potential for amplified noise

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to update healthcare professionals about additional LINQ IITM insertable cardiac monitors (ICM) which have the potential for amplified noise, following previous communication in November 2023. These devices 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 lead to missed/delayed diagnosis, delayed medical intervention, and early device replacement. The identified subset now includes 64,700 total devices. As of 1 May 2024, 553 (0.85%) devices have exhibited these characteristics, with no reports of serious harm. Healthcare professionals are advised to continue care of patients implanted with an affected ICM according to existing device labelling and refer to patient management recommendations in the letter. Please refer to the letter for details.

Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

3 Jul 2024

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.