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Medtronic Implantable Defibrillators

24 June 2022

Implant Hazard Alert - software update required

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), for devices manufactured before July 2021:

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 number of your device. If your device is in the table above and was manufactured before July 2021, you will need the software update. If you are unsure if your device is affected, please contact your cardiologist for further assistance.

If your device is affected, 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.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.