Potential for intermittent reduced-energy shock for Medtronic Cobalt XT™, Cobalt™ and Crome™ ICDs and CRT-Ds due to short circuit protection event

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of the potential for intermittent reduced shock energy during high-voltage (HV) therapy for Medtronic Cobalt™ and Crome™ implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds), due to short circuit protection (SCP) event. Potential harms related to an SCP event during the second-phase of the HV biphasic waveform delivery include failure to terminate the arrhythmia due to reduced-delivered-energy, a theoretical risk of proarrhythmia, and complications associated with device replacement, including unnecessary lead replacement due to misinterpretation of the SCP alert. A software update to address the issue is anticipated to be available for download into implanted devices by the fourth quarter of 2022. The update will ensure that the full shock energy is delivered in the presence of a secondary, low-level current pathway in the HV circuitry. While Medtronic is requesting hospitals to quarantine and return a subset of non-implanted Medtronic Cobalt™ and Crome™ ICDs and CRT-Ds, prophylactic device replacement is not recommended. Healthcare professionals are advised to follow up with their patients implanted with the affected devices according to the patient management recommendations provided in the letter. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

8 Jul 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.