VF zone ATP may not be automatically enabled and may require manual programming
ANZCDACC Advisory Notice 6 December 2020
Device: Medtronic Cobalt™ and Crome™ ICDs and CRT-Ds
Advisory grade TGA: Urgent Product Defect Correction
Boston Scientific EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) current model S-ICD lead/electrode (6 Dec 2020)
electrode body fractures at a location just distal to the proximal sense ring
ANZCDACC Advisory Notice 6th December 2020
Device: EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) current model S-ICD lead/electrode
Advisory grade TGA: TBA
Boston Scientific EMBLEM™ S-ICDs (Models A209 and A219) Implanted – May 2015 to Dec 2017 (6 December 2020)
Over time a pathway may develop in header that allows moisture ingress, enabling a shorting condition to occur during delivery of HV therapy
Device: EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) all Implanted from May 2015 to December 2017
6 December 2020
Advisory grade TGA: TBA
LivaNova Platinium ICD and CRTD (July 2018)
ANZCDACC Advisory Notice 2nd August 2018
Device:
LivaNova: Limited subset of Platinium ICD and CRTD
(Platinium VR 1210, Platinium VR 1240, Platinium DR 1510, Platinium DR 1540, Platinium CRT-D 1711, Platinium CRT-D 1741, Platinium SONR CRT-D 1811, Platinium SONR CRT-D 1841.)
Serial numbers of affected devices in Australia: 629DL05C, 650DL087, 638DD149, 639DD140, 639DD15E, 624DF096
TGA Reference: RC-2018-RN-00929-1
Australian Register of Therapeutic Goods (ARTG): 282817, 282816, 282818, 282819, 282820, 282821, 282822, 282823 respectively.
Medtronic Entrust VR/DR/AT ICDs. Models: D154ATG; D154VRC
ICD may become EOL with no prior ERI alert. May not be able to charge HV circuits, loss of HV and ATP. Brady continue to operate as expected.
ANZCDACC Advisory Notice 9th July 2018
Device:
Medtronic Entrust VR/DR/AT ICDs. Models: D154ATG; D154VRC
TGA Reference:
RC-2018-RN-00833-1
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.