| TGA Action ID |
RC-2025-RN-00924-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Aurora EV-ICD MRI SureScan
Aurora EV-ICD (DVEA3E4), Clinical EV-ICD (DVEX3E4) |
| ARTG Number |
450443 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In a subset of the above identified devices, there is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
A device update via CareLink SmartSync Device manager is available to eliminate this potential delay.
Through 2 October 2025, six (6) events (delay of 2-17 seconds) were observed among approximately 4,900 implanted devices worldwide (0.12%).
Five of the six events experienced this behaviour during a controlled defibrillation threshold test. While not observed clinically, a delay in HV therapy may impact defibrillation efficacy.
The root cause of this behaviour is related to the EV-ICD dynamic sensing algorithm becoming static if a charge-end occurs while the device is processing a sensed event. This will set the sensitivity to 53% of the prior R-wave amplitude. A subsequent R-wave amplitude that exceeds the static 53% level will restore automatic sensitivity operation and allow R-wave synchronisation for therapy delivery.
There have been zero reports of permanent harm or death due to this behaviour. |
| Instructions for Customers/Users |
Customers are asked to:
- Ensure their SmartSync application is updated to include the Aurora EV-ICD Application.
- Contact their Medtronic representative if assistance is needed.
- Each patient requires unique clinical considerations. Prophylactic device replacement is NOT recommended.
- Schedule an in-clinic SmartSync interrogation to receive the software update, with the intent for all patients to receive the update within the next 3-6 months.
- Individual devices susceptible to this behaviour can be identified via search/look-up on the Medtronic Product Performance Report Website ( http://productperformance.medtronic.com)
Medtronic has implemented manufacturing changes, and devices manufactured with this update are not susceptible to this delay. In previously distributed devices, a device interrogation with the CareLink SmartSync Aurora EV-ICD application (D00U025) on CareLink SmartSync Device Managers will resolve the potential for this behaviour.
This action has been finalised on 23/01/2026. |
| Action Commencement Date |
29/10/2025 |
| Responsible Entity |
|
| Contact Information |
0419 205 911 - Sharon Goodwin |