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Health Sciences Authority
Dear Healthcare Professional Letters

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

Audiences

Healthcare professional

Industry member

Product type

Medical devices

2 July 2024

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 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.

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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