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Health Sciences Authority
Dear Healthcare Professional Letters

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

Audiences

Healthcare professional

Industry member

Product type

Medical devices

4 July 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 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.

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 (opens in new tab) 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.