Loss of LV pacing of Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ when programmed from Managed Ventricular Pacing (MVP) mode to pacing mode with AdaptivCRT™ enabled
Healthcare professional
Medical devices
15 December 2016
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Medtronic International Limited would like to notify healthcare professionals of the loss of LV pacing that may occur with all models of Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ devices. Medtronic became aware that when a patient with AdaptivCRT enabled (shipped setting) is subsequently programmed to MVP mode and then re-programmed back to DDD or DDDR, AdaptivCRT is not re-enabled. When this programming sequence occurs, LV pacing is not delivered, despite parameters indicating AdaptivCRT is enabled. This will result in RV only pacing, which may be undesirable for the patient. LV pacing will remain disabled until a specific programming sequence is manually completed. A software update is being developed to address this issue. In the meantime, healthcare professionals are advised to follow the programming recommendations to manage patients with the susceptible device until the software update is available. Please refer to 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.
