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

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.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

22 Apr 2022

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). HPP is 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: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

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

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