Category: Device Alerts

ANZCDACC Product Defect Correction and Implant Hazard Alert June 2021

Device: Medtronic Reveal LINQ with TruRhythm Cardiac Monitoring Systems

 TGA Reference: RC-2021-RN-01276-1

Australian Register of Therapeutic Goods (ARTG): 218791

Advisory grade TGA: Class II

(Class II recall action occurs when the product deficiency could cause illness, injury or result in mistreatment, but are not class I.)

ANZDACC Advisory Grade: Routine

ANZCDACC Safety Alert Notice March 21^st 2021

Device:

Subset Biontronik Ilesto, Inventra, Iperia, Itrevia, Ilivia, Intica, Intica Neo ICDs and CRT-D implanted since 2013

TGA Reference: RC-2021-RN-00667-1

Advisory grade TGA:  Class I

(Class I recall action occurs when the product deficiency is potentially life threatening or could cause serious risk to health)

ANZDACC Advisory Grade: Routine

Number of CIEDs affected in Australia and New Zealand:

Australia Approximately  2000

New Zealand Approximately 500

ANZCDACC Product Notification Notice 22^nd November 2019

UPDATE: 4^th of Feb 2021 – Updated text in purple.

Device:

Product	ARTG
Claria MRI™ CRT-Ds	280183; 280186 ; 281607; 281608
Amplia MRI™ CRT-Ds	280182; 280184 ; 281606
Compia MRI™ CRT-Ds	280181 ; 280185
Viva™ CRT-Ds	203210 ; 203211; 203212; 203840; 219221; 219222; 230204
Brava™ CRT-Ds	219220
Visia AF™ ICDs	280351; 280352; 280353
Visia AF MRI™ ICDs	280354; 280355; 282960; 282961
Evera™ ICDs	206324; 208024; 208025; 208026; 208027; 208028; 208029; 208030
Evera MRI™ ICDs	208030; 230019; 230020; 230021; 230022; 281609; 281610; 281611; 281612
Primo MRI™ ICDs	312640 ; 312641; 312642; 312643
Mirro MRI ™ ICDs	Not sold in Australia

TGA Reference: RC-2019-RN-01641-1

Advisory grade TGA: TBA

ANZDACC Advisory Grade: Routine

Number of CIEDs affected in Australia and New Zealand: TBA

ANZCDACC Product Defect Correction Notice August 2019

Device:

1. Model A209 EMBLEM ^TM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs)
2. Model A219 EMBLEM MRI Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs)

ARTG:

1. 260382
2. 286705

ANZCDACC Safety Alert Notice 21 December 2020

Device:

1. Model A209 EMBLEM ^TM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs)
2. Model A219 EMBLEM MRI Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs)

 

ANZCDACC Advisory Notice 6^th December 2020

Device:  EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) current model S-ICD lead/electrode

ANZCDACC Advisory Notice 6^th December 2020

Device: EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) all Implanted from May 2015 to December 2017

ANZCDACC Advisory Notice 6^th December 2020

Device:  Medtronic Cobalt™ and Crome™ ICD and CRT-D

ANZCDACC Product Notification Notice 22^nd November 2019

Device:

Product	ARTG
Claria MRI™ CRT-Ds	280183; 280186 ; 281607; 281608
Amplia MRI™ CRT-Ds	280182; 280184 ; 281606
Compia MRI™ CRT-Ds	280181 ; 280185
Viva™ CRT-Ds	203210 ; 203211; 203212; 203840; 219221; 219222; 230204
Brava™ CRT-Ds	219220
Visia AF™ ICDs	280351; 280352; 280353
Visia AF MRI™ ICDs	280354; 280355; 282960; 282961
Evera™ ICDs	206324; 208024; 208025; 208026; 208027; 208028; 208029; 208030
Evera MRI™ ICDs	208030; 230019; 230020; 230021; 230022; 281609; 281610; 281611; 281612
Primo MRI™ ICDs	312640 ; 312641; 312642; 312643
Mirro MRI ™ ICDs	Not sold in Australia

 

ANZCDACC Advisory Notice 17th January 2019

Device: Programmer Software Update supporting the Micra Transcatheter Pacing System (TPS)

Medtronic 2090 Carelink Programmer, 29901 Encore Programmer, Carelink Network Application software 2491