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Health Sciences Authority
Dear Healthcare Professional Letters

Updates to the Instructions for Use and Patient Manual for Medtronic Heartware HVAD™ System

Audiences

Healthcare professional

Industry member

Product type

Medical devices

11 March 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 of the upcoming updates to the Instruction for Use (IFU) and Patient Manual (PM) for the Medtronic HeartWare™ Ventricular Assist Device (HVAD™) System. These updates include new information on the useful life of the HVAD™ System carrying cases (Waist Pack, Shoulder Pack, and Convertible Patient Pack) and clarifications on the HVAD™ Controller connections, power-up sequence, and notifications as well as the expected duration of HVAD™ System alarms. The PM is also updated to inform users on the care and use instructions for the HVAD™ System carrying cases and information related to the HVAD™ Controller driveline cover. Healthcare professionals are advised to review the updated IFU and PM and to share the information with their patients as needed. 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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