Notification of a subset of Medtronic LINQ II™ ICM Systems (LNQ22) with potential issue for amplified noise and/or overall signal reduction
Healthcare professional
Industry member
Medical devices
14 November 2023
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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.
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.
