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: 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
The St Jude Medical Riata ICD lead, is currently the subject of a hazard alert. This is related to failure of the silicone insulation.
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)
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
Device: Reply and Esprit DR (Dual Chamber) and SR (Single Chamber) Pacemakers