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

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.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

11 Jun 2021

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), 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: Select your profession under 'For Healthcare Professionals’.

Step 2: Click on 'Restricted Content' and log in via SingPass.

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

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