| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00929-1 |
| Product Name/Description |
Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)
PLATINIUM VR 1210
ARTG No: 282817
PLATINIUM VR 1240
ARTG No: 282816
PLATINIUM DR 1510
ARTG No: 282818
PLATINIUM DR 1540
ARTG No: 282819
PLATINIUM CRT-D 1711
ARTG No: 282820
PLATINIUM CRT-D 1741
ARTG No: 282821
PLATINIUM SONR CRT-D 1811
ARTG No: 282822
PLATINIUM SONR CRT-D 1841
ARTG No: 282823 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/07/2018 |
| Responsible Entity |
|
| Reason/Issue |
On a subset of Platinium ICD and CRT-D devices, a specific hardware configuration was identified as potentially defective over time, leading to overconsumption, immediately followed by a loss of pacing and sensing capabilities in all cavities. As a result of this loss of sensing capability, the device cannot identify an arrhythmia that would normally require defibrillation shock therapy.
No permanent injury or death has been reported as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Regarding the medical device recall:
Microport CRM is initiating a removal of the non-implanted Platinium devices that may present with this hardware failure and providing recommendations for managing implanted patients; and
Regarding the implant hazard alert:
In order to mitigate the potential risks associated with the loss of the device pacing and sensing capabilities, Microport CRM recommends physicians follow-up the patients at the periodicity already stated in the implant manual.
This action has been closed out on the 21/11/2018. |
| Contact Information |
03 9799 7444 - LivaNova |