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.
Boston Scientific: AUTOGEN DR ICDs and CRT-Ds (14 Dec 2014)
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
Boston Scientific: COGNIS Implantable CRT-Ds and TELIGEN DR & VR ICDs – Addendum (10 Oct 2014) from previous (5 Sept 2013)
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
Management of Riata leads at time of generator change
The St Jude Medical Riata ICD lead, is currently the subject of a hazard alert. This is related to failure of the silicone insulation.
ANZCDACC Advisory Notice 21st August 2014
Device: St Jude Ellipse VR and DR Implantable Cardioverter Defibrillators Model Nos.: CD1277 ( ‐ 36 and ‐ 36Q), CD1377 ( ‐ 36, ‐ 36Q, ‐ 36C and ‐ 36QC), CD2277 ( ‐ 36 and ‐ 36Q), CD2377 ( ‐ 36, ‐ 36Q, ‐ 36C and ‐ 36QC)
ANZCDACC Advisory Notice 29th January 2014
Device: St. Jude Medical ICDs and CRT-Ds programmed with Merlin Programmer Software Version 17.2.2 rev. 0 Inappropriate Programmer Setting of Return to Sinus Detection Criteria in SJM ICDs and CRT-Ds Programmed to a Single VF Detection Zone