Dear Healthcare Professional Letters
Technical programming information for Cardiac Resynchronization Therapy pacemakers (VALITUDE™, VISIONIST™) and defibrillators (CHARISMA™ , MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™) - Left Ventricular Offset Interaction
Audiences
Healthcare professional
Product type
Medical devices
10 January 2018
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Boston Scientific Asia Pacific Pte Ltd would like to inform healthcare professionals of the unintended asynchronous biventricular (BiV) pacing behaviour in Cardiac Resynchronization Therapy pacemakers (VALITUDE™, VISIONIST™) and defibrillators (CHARISMA™ , MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™). This letter outlines the important reprogramming information to prevent this behaviour when tracking elevated atrial intrinsic rhythms in affected devices. Repeated detection of this unintended asynchronous BiV pacing behaviour may result in the implanted device reverting to a permanent Safety Mode (Safety Core™) status thus requiring early replacement. Healthcare professionals are advised to follow the enclosed programming recommendations to eliminate the risks associated with early device replacement. Please refer to the letter for details.
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Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.