Potential shortened service time for a subset of Medtronic Implantable Cardioverter Defibrillators and Cardiac Resynchronisation Therapy Defibrillators

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of a potential shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval for a subset of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) due to a latent shorting mechanism in the battery. The subset of ICDs and CRT-Ds affected by this issue were last implanted in February 2019 and manufactured with a specific battery design that is no longer being distributed. No reports of permanent harm to patients resulting from this issue have been received. Healthcare professionals are advised to continue normal follow-up per local clinical protocol. If unexpected RRT is observed, device replacement is recommended immediately for pacing-dependent patients and within a week for non-pacing or primary prevention ICD patients. Prophylactic replacement is not recommended due to the low rate of occurrence and the low potential for permanent harm when prompt replacement occurs in response to an unexpected RRT. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

10 Feb 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). 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.