ANZCDACC – Advisory Notice: 1 November 2016
Device: LivaNova Field Safety Notice Applicable to REPLY Models D, DR, VDR, SR ESPRIT Models D, DR, S, SR, FACIL Model DR pacemakers
ANZCDACC Advisory Notice: 30 August 2016 – Medtronic Viva Cardiac Resynchronisation Therapy Defibrillators and Evera Implantable Cardioverter Defibrillators
ANZCDACC Advisory Notice 30 August 2016
Device: Medtronic Viva Cardiac Resynchronisation Therapy Defibrillators and Evera Implantable Cardioverter Defibrillators
Note: The advisory has only been issued for one particular batch of these generators consisting of 78 devices worldwide. No other Viva or Evera devices are affected.
ANZCDACC Advisory Notice 7 March 2016 – Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)
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
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
24 November Addendum to ANZCDACC Advisory Notice 12 November 2015
Device: St Jude Optisure Dual Coil Defibrillation Leads
St Jude Optisure Dual Coil Defibrillation Leads (12Nov2015) and Addendum (24 Nov2015)
Device: St Jude Optisure Dual Coil Defibrillation Leads
download 12 November 2015 notice (pdf)
download Nov 2015 Addendum (pdf)
27 August 2015 Update to ANZCDACC Advisory Notice 22 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.
Important information regarding Philips aSV devices
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.
HAZARD ALERT all models of RF enabled St. Jude Medical Implantable Cardioverter Defibrillators and Pacemakers
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.