ANZCDACC Advisory Notice 7 March 2016
Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM) Model LNQ11 8042, 8042B, 8042U
ANZCDACC Advisory Notice 7 March 2016
Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM) Model LNQ11 8042, 8042B, 8042U
ANZCDACC Advisory Notice 25 November 2015
Device: Medtronic InSync III Cardiac Resynchronization Therapy Pacemakers (CRT-P) Models 8042, 8042B, 8042U
24 November Addendum to ANZCDACC Advisory Notice 12 November 2015
Device: St Jude Optisure Dual Coil Defibrillation Leads
Device: St Jude Optisure Dual Coil Defibrillation Leads
download 12 November 2015 notice (pdf)
download Nov 2015 Addendum (pdf)
Device: All models of RF enabled St. Jude Medical Implantable Cardioverter Defibrillators (Ellipse Fortify Assura, Unify Assura, and Quadra Assura) and Pacemakers (Assurity and Allure) when used with Merlin@home RF Remote Monitor Model EX1150.
Current patients should be evaluated and a discussion about whether to discontinue ASV therapy should occur if a current patient is found to be in the at-risk population. If it is unknown whether a current patient falls within the at-risk population, the patient should be evaluated to determine if ASV therapy should continue.
Do not place new patients with symptomatic chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea on ASV therapy. Before putting patients on ASV, each patient should be assessed for Heart Failure. In case of signs and symptoms of Heart Failure an objective assessment of LVEF should be performed.
ANZCDACC Advisory Notice 22nd December 2014
Device: All models of RF enabled St. Jude Medical Implantable Cardioverter Defibrillators (Ellipse Fortify Assura, Unify Assura, and Quadra Assura) and Pacemakers (Assurity and Allure) when used with Merlin@home RF Remote Monitor Model EX1150.
Boston Scientific: AUTOGEN DR ICDs and CRT-Ds (14 Dec 2014)
Number in Australia: Currently 162 devices at risk (67 DR and 95 CRT-D)
Risk: All devices have potential issue – clinical consequence dependent on pacing status
10 October 2014 Addendum Link to ANZCDACC Advisory Notice – 5 September 2013
In addition to the original advisory below
Device: Boston Scientific: COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs) Manufactured prior to December 2009