| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01604-1 |
| Product Name/Description |
Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan
Amplia MRI CRT-D SureScan/Amplia MRI Quad CRT-D SureScan
Models: DTMB2D1, DTMB2D4, DTMB2QQ
Claria MRI CRT-D SureScan/ Claria MRI Quad CRT-D SureScan
Models: DTMA2D1, DTMA2D4, DTMA2Q1, DTMA2QQ
Multiple ARTG numbers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic is writing to inform Physicians about a software issue that could result in the loss of LV pacing that occurs following a specific device programming sequence. If it occurs, this issue can be corrected by re-programming the device. All tachyarrhythmia detection and therapy features remain fully operational. The issue can only occur in devices that have been programmed from Managed Ventricular Pacing (MVP) mode to a pacing mode with AdaptivCRT enabled. When a patient with AdaptivCRT enabled (shipped setting) is subsequently programmed to MVP mode and then re-programmed back to DDD or DDDR, AdaptivCRT is not re-enabled. When this programming sequence occurs, LV pacing is not delivered, despite parameters indicating AdaptivCRT is enabled.
Through 10 November 2016, two events have been reported to Medtronic related to this issue. A review of the data revealed an overall occurrence rate of 0.38%. Medtronic has not received any reports of patient injury related to this issue. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
A software update is being developed by Medtronic to address this issue in Claria MRI and Amplia MRI devices. This software update will also address an unrelated transient mode switch behaviour in all Quadripolar models of Claria MRI, Amplia MRI, and Compia MRI CRT-D SureScan devices. Further information will be communicated once the software update receives applicable regulatory approvals. Until the software update has been approved and the affected models receive the update, Physicians are advised to follow the programming recommendations in the customer letter. These recommendations also apply to any new device implants.
This action has been closed out on the 01/11/2018. |
| Contact Information |
02 9857 9052 - Medtronic Product Manager |