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Health Sciences Authority
Dear Healthcare Professional Letters

Reveal LINQ™ with TruRhythm™ Insertable Cardiac Monitoring Systems: Brady & Pause detections disabled following partial electrical reset

Audiences

Healthcare professional

Industry member

Product type

Medical devices

7 June 2021

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 inform healthcare professionals that Reveal LINQ™ with TruRhythm™ Insertable Cardiac Monitoring Systems (ICMs) that undergo a partial electrical reset appear to be "ON", but are no longer able to detect and report Brady and Pause events. This is due to an error in the partial electrical reset implementation. Potential harms include those associated with the risk of delayed medical intervention or missed diagnosis for Brady and Pause events, and an explant procedure. Currently implanted or distributed Reveal LINQ™ with TruRhythm™ ICMs will receive a future software update to correct this issue delivered via the Model 2090 and Encore™ programmers. Healthcare professionals are advised to carefully monitor their patients' devices and contact their Medtronic Representative if a partial electrical reset occurs. 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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