ADDENDUM – ANZCDACC Advisory Notice 5th September 2013 Device: Boston Scientific: COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs)

10th October 2014

Addendum to ANZCDACC Advisory Notice 5th 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

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) Advisory Grade TGA: Class I Hazard Alert (Implanted devices) and Recall (Devices on shelves)

ANZDACC Advisory Grade: Semi Urgent

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

Advisory Grade: Hazard Alert (Implanted Devices)