Device Alerts

electrode body fractures at a location just distal to the proximal sense ring

ANZCDACC Advisory Notice 6^th December 2020

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

Advisory grade TGA: TBA

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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

 

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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

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Update required to display correct longevity estimate for Micra TPS

Device: Programmer Software Update supporting the Micra Transcatheter Pacing System (TPS):  Medtronic 2090 Carelink Programmer, 29901 Encore Programmer, Carelink Network Application software 2491

ANZCDACC Product Defect Correction Notice 17th Jan 2019

ARTG: 116038 & 213024

TGA Reference: RC-2019-RN-00079-1

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If error occurs, device will withhold pacing until a VS detected

ANZCDACC Advisory Notice 24th January 2019

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Device: Medtronic Adapta DR: Model numbers affected

Affected Model numbers	ARTG
ADDR01	125076
ADDR03	125077
ADDR06	125078
ADDRL1	125084
ADDRS1	125085
ADVDD01	125080

Not all Adapta devices are affected by this recall. Patients and clinicians may determine if a specific device is affected by looking up the serial number of Medtronic’s Product Performance website.

TGA Reference: RC-2019-RN-00080-1

Shortened replacement interval after ERI

Device: Cameron Health Incorporated (Boston Scientific) SQ-RX Model 1010 (First generation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD))

ANZCACC Advisory Notice 18th January 2019

ARTG: 219499 (Discontinued)

TGA Reference: RC-2018-RN-01427-1

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Vulnerable to being hacked when connected to internet for software upgrades

Device: Medtronic Carelink 2090 and the Carelink Encore 29901/29901A programmers (All serial numbers)

ANZCDACC Advisory Notice 18th January 2019

 

TGA Reference:  RC-2018-RN-01351-1

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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.

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

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Device:

Medtronic Entrust VR/DR/AT ICDs. Models: D154ATG; D154VRC

TGA Reference:

RC-2018-RN-00833-1

Intermittent over sensing of Minute Ventilation sensor causing periods of pacing inhibition.

ANZCDACC Advisory Notice 24^th December 2017

Device: Boston Scientific VALITUDE™ CRT-P Model U128, VISIONIST™ CRT-P Models U225, U226, U228, ACCOLADE™ Pacemakers Models L310, L311, L331,  PROPONENT™ Pacemakers Models L210, L211, L231

TGA Reference:  RC-2017-RN01509-1

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