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Health Sciences Authority
Dear Healthcare Professional Letters

Software update for CareLink SmartSync™ Device Managers to correct potential telemetry error associated with Medtronic Cobalt™ and Crome™ ICDs and CRT-Ds

Audiences

Healthcare professional

Industry member

Product type

Medical devices

21 April 2022

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 a software update (software application D00U005 version 6.0.3 or higher) for CareLink SmartSync™ Device Managers to correct a telemetry error that may occur with Medtronic Cobalt™ and Crome™ implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The affected Cobalt™ and Crome™ devices may encounter a persistent "Session Active" flag following the use of inductive telemetry through the SmartSync™ device manager if the telemetry signal is intermittent or disrupted at the end of the interrogating session. A persistent "session-active" flag will result in temporary suspension of features such as battery voltage measurements, Capture Management™, AdaptivCRT™ and Wavelet™ template management. Potential risks include the loss of pacing or inadequate CRT support, and/or loss of Recommended Replacement Time (RRT) indicator. Devices manufactured after July 2021 have already received the software update and are not susceptible to the described behaviour. Healthcare professionals are advised to follow the recommendations and instructions provided in the letter to update the SmartSync™ application software. 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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