Device Alerts

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

Expansion of issue reported in 2018. hydrogen-induced accelerated battery depletion. No follow up change required

ANZCDACC Advisory Expansion June 2021

Download June 2021 as pdf

 Download previous of 2018 

Device: Boston Scientific ACCOLADE™, PROPONENT™, ESSENTIO™ & ALTRUA 2™ pacemakers and VISIONIST™ and VALITUDE™ CRTPs.

Model numbers: L100, L101, L110, L111, L121, L131, L200, L201, L209, L210, L211, L231, L300, L301, L310, L311, L321, L331, S701, S702, S722, U125, U128, U225, U226, U228.

 

TGA Reference: RC-2021-RN-01304-1

Australian Register of Therapeutic Goods (ARTG): 280319, 280316, 280315, 279330, 279331 and 279332

 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

 

May initiate Safety Mode related to telemetry attempts.  Basic therapy is still provided in Safety Mode, replacement is required.

ANZCDACC Implant Hazard Alert June 2021

Download as pdf

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

 

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

Incomplete epoxy mixing causing moisture into header, causing loss of telemetry, reduced longevity, loss of pacing and shorter ERI to EOS time

ANZCDACC Field Safety Notice 15 March 2021

Download as pdf

Device:

A subset of Abbott / St Jude Medical Assurity™ and Endurity™ Pacemakers
Models: PM1160, PM1172, PM1240, PM1272, PM2160, PM2172, PM2240, PM2260*, PM2272

TGA Reference: RC-2021-RN-00728-1
Australian Register of Therapeutic Goods (ARTG): 216288, 267515, 216284, 267512, 216289, 267514, 216285, 216287*, 267513
*TGA listing cancelled in June 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

Latent shorting mechanism resulting from lithium plating between annode and cathode causing rapid battery depletion 

ANZCDACC Product Notification Notice 22^nd November 2019

Device: Medtronic: Subset of CRT-Ds and ICDs

Download as pdf 

 expanding RC-2019-RN-01242-1 device population with increased likelihood of a low voltage capacitor causing accelerated battery depletion

ANZCDACC Safety Alert Notice 21 December 2020

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

Medsafe Reference Number: 26965

TGA Reference: RC-2020-RN-01312-1

download as pdf

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

Download  as pdf 

Advisory grade TGA: Urgent Product Defect Correction