Category: Device Alerts

ANZCDACC Implant Hazard Alert June 2021

Device: Boston Scientific dual chamber INGENIO family pacemakers and Cardiac resynchronisation (CRTPs).

Models: ADVANTIO DR EL (K084, K087), INGENIO DR EL (K184, K187), VITALIO DR EL (K287), INVIVE CRT-P (V182, V183)

 TGA Reference: RC-2021-RN-01305-1

Australian Register of Therapeutic Goods (ARTG): 194925, 194926, 194927, 202980, 202981, 202982, 213922, 213923, 213924, 213925, 213926, 213927, 194920, 194921, 194924, 202999, 203000, 203004, 213930, 213931, 194928 and 194929

Advisory grade TGA: Class I

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

ANZDACC Advisory Grade: Semi-urgent

Device:

Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)

 TGA Reference:

Australian Register of Therapeutic Goods (ARTG):
339481, 339482, 339483, 339484, 339485, 339486, 339487, 339488, 339489, 339490, 339491, 339492, 341547, 341548, 341549, 341551, 341552, 341555, 341556, 341557, 341558, 341553, 341550, 341554

Wand Notification:
200109-WAND-6TXFRQ, 200109-WAND-6TXFSH, 200109-WAND-6TXFVH, 200109-WAND-6TXFTE, 200109-WAND-6TXFTX, 200109-WAND-6TXG78, 200109-WAND-6TXFST, 200109-WAND-6TXFU9, 200109-WAND-6TXFT3, 200109-WAND-6TXG6G, 200109-WAND-6TXFTO, 200109-WAND-6TXG7J, 200109-WAND-6TXFPN, 200109-WAND-6TXFO3, 200109-WAND-6TXFJ5, 200109-WAND-6TXFOK, 200109-WAND-6TXFQB, 200109-WAND-6TXFQ1, 200109-WAND-6TXFOZ, 200109-WAND-6TXFP9, 200109-WAND-6TXFQO, 200109-WAND-6TXFN0, 200109-WAND-6TXFKX, 200109-WAND-6TXFNA

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.)

ANZCDACC Product Defect Correction Notification

Device:

Merlin™ Patient Care System (PCS) Software Model 3330 v25.0.X–v25.3.X

GTIN 05414734509725

When used with

Abbott Gallant™, Neutrino™ NxT, Entrant™ devices

Note:

1. In Australia; Neutrino™ NxT and Entrant ™ are currently approved but not commercially launched (Only Gallant is commercially available).
2. In New Zealand; Only Gallant and Entrant are Medsafe WAND notified however only Entrant has been commercially launched at limited accounts.

 TGA Reference:

Australian Register of Therapeutic Goods (ARTG):

124262

Advisory grade TGA:

Class II

Class II- A situation in which use of, or exposure to, the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Device:
All Medtronic Cobalt™ and Crome™ ICDs and CRTDs. Namely:
Cobalt™:
Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DDPA2D4; Cobalt DR: DDPB3D1, DDPB3D4; Cobalt XT HF: DTPA2D4, DTPA2D1; Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1; Cobalt HF: DTPB2D4, DTPB2D1; Cobalt HF Quad: DTPB2QQ, DTPB2Q1
Crome™:
Crome VR: DVPC3D1, DVPC3D4; Crome DR: DDPC3D1, DDPC3D4; Crome HF: DTPC2D4, DTPC2D1; Crome HF Quad: DTPC2QQ, DTPC2Q1

TGA /Medsafe Reference:
Australian Register of Therapeutic Goods (ARTG): 313620
Medsafe Reference: 28468

Advisory grade TGA:
Not listed on TGA website but likely 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 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