electrode body fractures at a location just distal to the proximal sense ring
ANZCDACC Advisory Notice 6th December 2020
Device: EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) current model S-ICD lead/electrode
Advisory grade TGA: TBA
electrode body fractures at a location just distal to the proximal sense ring
ANZCDACC Advisory Notice 6th December 2020
Device: EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) current model S-ICD lead/electrode
Advisory grade TGA: TBA
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
May have compromised performance of an electrical component causing accelerated battery depletion
ANZCDACC Product Defect Correction Notice August 2019
Device:
ARTG:
TGA Reference: RC-2019-RN-01242-1
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
If error occurs, device will withhold pacing until a VS detected
ANZCDACC Advisory Notice 24th January 2019
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
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
ANZCDACC Advisory Notice 2nd August 2018
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
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 24th 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