The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning Amplia MRI Cardiac resynchronization therapy devices (CRT-D) SureScan and Claria MRI CRT-D SureScan, manufactured by Medtronic.
According to the manufacturer, there is 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 the manufacturer related to this issue. A review of the data revealed an overall occurrence rate of 0.38%. The manufacturer has not received any reports of patient injury related to this issue.
A software update is being developed by the manufacturer 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. Until the software update has been approved and the affected models receive the update, physicians are advised to follow the programming recommendations provided by the manufacturer. These recommendations also apply to any new device implants.
According to the local supplier, the affected products [Ampila MRI CRT-D (DTMD2D4) and Ampila MRI Quad CRT-D SureScan (DTMB2QQ)] are distributed in Hong Kong.
For details, please refer to the TGA website:
https://www.tga.gov.au/alert/medtronic-crt-ds-various-models
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 December 2016