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
ANZCDACC Advisory Notice 4th December 2013
Device: Reply and Esprit DR (Dual Chamber) and SR (Single Chamber) Pacemakers
Reply and Esprit DR (Dual Chamber) and SR (Single Chamber) Pacemakers (4 December 2013)
Australian and New Zealand Cardiac Device Advisory and Complications Committee (ANZCDACC)
Device: Reply and Esprit DR (Dual Chamber) and SR (Single Chamber) Pacemakers
Advisory Grade: Hazard Alert (Implanted Devices)
ANZCDACC Advisory Grade: Elective/Routine
Number in Australia: Approximately 1500 at risk
Description: Erroneous residual battery longevity displayed by pacemaker programmer. When the device approaches ERI, the overestimation of battery longevity could results in ERI or EOL being reached between follow up visits.
Advice: Frequent follow-up period recommendation has been changed: a maximum of 6 months follow-up interval when the battery impedance becomes greater or equal to 3.5 kΩ, instead of 5kΩ previously. This recommendation applies also after the correction. This Hazard Alert will be corrected in the new programmer software version (V2.4) which will be installed on all Sorin programmers (Orchestra and Orchestra Plus) within the next 3 months.