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Health Sciences Authority
Dear Healthcare Professional Letters

Increased potential for reduced energy or no energy delivered during HV Therapy in specific Medtronic ICDs and CRT-Ds when programmed with the AX>B pathway

Audiences

Healthcare professional

Industry member

Product type

Medical devices

25 May 2023

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, Ltd. to inform healthcare professionals of the rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a glassed feedthrough. When devices in the glassed feedthrough population are programmed exclusively in the B>AX configuration, the potential for a reduced- or no-energy HV therapy is comparable to historical device performance. Potential harms related to reduced- or no-energy output during HV therapy include failure to terminate an arrhythmia, as well as complications associated with device replacement and/or unnecessary lead replacement if the reduced- or no-energy HV therapy is erroneously attributed to a lead failure. Prophylactic device replacement is not recommended.  Healthcare professionals are advised to program all HV therapy pathways to B>AX in all therapy zones, prioritise reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B, and to follow up with their patients implanted with 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 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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