Medtronic Australasia Pty Ltd is updating the software for the following models of Cobalt and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds):
|Cobalt Models||Crome Models|
|Cobalt XT VR: DVPA2D1, DVPA2D4||Crome VR: DVPC3D1, DVPC3D4|
|Cobalt VR: DVPB3D1, DVPB3D4||Crome DR: DDPC3D1, DDPC3D4|
|Cobalt XT DR: DDPA2D1, DDPA2D4||Crome HF: DTPC2D4, DTPC2D1|
|Cobalt DR: DDPB3D1, DDPB3D4||Crome HF Quad: DTPC2QQ, DTPC2Q1|
|Cobalt XT HF: DTPA2D4, DTPA2D1|
|Cobalt HF: DTPB2D4, DTPB2D1|
|Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1|
|Cobalt HF Quad: DTPB2QQ, DTPB2Q1|
What do I need to do?
Check your Patient Implant Card which you received when you had the device implanted. It will show the model and date of manufacture of your device. If your device is in the table above and was manufactured before July 2021, you will need the software update.
Make an appointment to see your cardiologist as soon as possible. They will have the new software to update your defibrillator.
What is the issue?
A software fault may cause loss of pacing or inadequate CRT support, and/or loss of the Recommended Replacement Time (RRT) indicator. These features can be restored with a SmartSync programmer session with your cardiologist.
0.3% of devices worldwide have experienced this problem. To date, no serious adverse events or permanent harms associated with it have been reported.
How will this issue be fixed?
Medtronic is updating the software for the SmartSync Device Manager tablets, used by clinicians, to version 6.0.3 or higher. This will allow affected devices to then receive the necessary software update.
Consumers and health professionals are encouraged to report problems with medical devices