ANZCDACC Advisory Notice 21st Decemember 2016 – Medtronic Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ Cardiac Resynchronization Therapy Defibrillators (CRT-D) Models DTMB2D1 DTMB2D4 DTMB2QQ DTMA2D1 DTMA2Q1 DTMA2QQ DTMA2D4

Device:  Medtronic  Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ Cardiac Resynchronization Therapy Defibrillators (CRT-D) Models DTMB2D1 DTMB2D4 DTMB2QQ DTMA2D1 DTMA2Q1 DTMA2QQ DTMA2D4

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.

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.