Abbott: Merlin™ Patient Care System (PCS) Software used in Gallant™, Neutrino™ NxT, Entrant™ devices (March 2022)

If “Hold to Test” pressed and released prior to first voltage decrement, the programmer may continue the Decrement Test instead of terminating the test.

Download as pdf

Device:  Abbott: 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

TGA Reference:

Australian Register of Therapeutic Goods (ARTG):  124262

 

Medtronic: Reveal LINQ™ with TruRhythm™ ICMs (June 2021)

After partial electrical reset, usually after DCCV or electrocautery, Brady & Pause events appear to be “ON,” but are no longer able to detect / report.

ANZCDACC Product Defect Correction and Implant Hazard Alert June 2021

Download as pdf 

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

Boston Scientific Emblem™ and Emblem MRI™ (S-ICDs) (update June 2021, previous August 2019)

 May have compromised performance of an electrical component causing accelerated battery depletion

Download June 2021 as a pdf

 Download August 2019 as a pdf 

Device:

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

ARTG:

  1. 260382
  2. 286705

TGA Reference: RC-2019-RN-01242-1

 

Biotronik : Ilesto™, Inventra™, Iperia™, Itrevia™, Ilivia™, Intica™, Intica Neo™ ICDs and CRT-Ds distributed since 2013 (21 March 2021)

Potential for lithium plating in battery that may cause a battery drain at a higher rate than under typical use. 

ANZCDACC Safety Alert Notice 21 March 2021 (Download pdf)

Device: Biotronik:  Ilesto™, Inventra™, Iperia™, Itrevia™, Ilivia™, Intica™, Intica Neo™ ICDs and CRT-D implanted since 2013

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

Medtronic: Subset of CRT-Ds and ICDs, Updates (Sept & Feb 2021) from previous (22 Nov 2019)

Sept 2021:   This is the same alert (RC-2019-RN-01641-1) which has been reclassified by the TGA to an “implant hazard alert”. No change from previous advice or risk: Latent shorting mechanism resulting from lithium plating between annode and cathode causing rapid battery depletion 

4 Feb 2021: Update to RC-2019-RN-01641-1  Latent shorting mechanism resulting from lithium plating between annode and cathode causing rapid battery depletion 

Download Sept 2021 as pdf

Updated in 4 Feb 2021 below (see purple text)    

Link to previous notification: ANZCDACC Product Notification Notice 22 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

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

Boston Scientific Model A209 Emblem™ S-ICDs and Model A219 Emblem MRI™ S-ICDs (August 2019)

May have compromised performance of an electrical component causing accelerated battery depletion

ANZCDACC Product Defect Correction Notice August 2019

Device:

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

ARTG:

  1. 260382
  2. 286705

TGA Reference: RC-2019-RN-01242-1

Download pdf