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
Advisory grade TGA: Urgent Product Defect Correction
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
Advisory grade TGA: Urgent Product Defect Correction
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.