| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00913-1 |
| Product Name/Description |
Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
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
ARTG Numbers: 282817, 282816, 282818, 282819, 282820, 282821, 282822 and 282823 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
LivaNova has identified an issue of overconsumption following an ElectroStatic Discharge (ESD) during implant surgery or an MRI scan.
An electronic component in specific Platinium devices has been found to be sensitive to ESD, potentially generated during surgery. The discharge can trigger overconsumption of current, leading to reduced device longevity (5% loss per month). Resetting the device will stop the overconsumption, but the residual longevity displayed by the programmer may be temporarily underestimated.
Exposure to an MRI's magnetic field can cause overconsumption, & the battery voltage will decrease to 2.80V. At this level, the remaining longevity is 25% of the initial longevity.
To date, no permanent injury or death has occurred as a result of these issues. As of 16 June 2017, LivaNova has received 18 reports of overconsumption associated with ESD exposure at implant, (0.19%), & 4 reports of overconsumption/premature device replacement attributed to MRI (0.04%). |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
In order to mitigate the potential risks associated with both triggering events (ESD/MRI scan), LivaNova recommends physicians follow-up patients at the periodicity already stated in the implant manual, especially:
- Before the patient is discharged & at each subsequent follow-up, check the battery status & the occurrence of system warnings;
- It is recommended that a routine follow-up examination be done 1 month after discharge, & then every 3 months until the device nears the replacement date.
LivaNova does not recommend anticipating patient visits, provided that the IFU is followed.
If the warning “[A3] Technical issue” is displayed, this indicates that the device is affected by the overconsumption caused by an ESD at implant. Without delay, contact your LivaNova representative who will organise the reset of the device.
Complete and return the supplied Customer Reply Form ASAP.
For further information, please see https://www.tga.gov.au/alert/platinum-icds-and-crt-ds
This action has been closed out on 12/10/2018 |
| Contact Information |
03 9799 7444 - LivaNova |