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Health Sciences Authority
Dear Healthcare Professional Letters

Instructions for Use Update of Medtronic Micra™ Delivery System on tether removal during implant

Audiences

Healthcare professional

Product type

Medical devices

28 August 2019

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 of the Instructions for Use (IFU) update of Medtronic Micra™ Delivery System as part of the Micra™ Transcatheter Pacing System. Medtronic has identified that flushing the delivery system after the tether has been cut may cause the free end of the tether to enter the ventricular chamber and tangle. If this happens, the tangle could potentially prevent tether removal from the delivery system and prevent release of the Micra pacemaker. Therefore, Medtronic is updating the IFU and Implant Procedure Tip Card to include the recommendation “Once the tether is cut, do not flush the delivery system until the tether has been fully removed.” Healthcare professionals are advised to implement this new instruction in all future Micra implant procedures. 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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