Australia’s TGA Issues Alerts for Medtronic Defibrillators, Other Devices

Australia’s Therapeutic Goods Administration has issued safety alerts for Medtronic Australasia’s cardiac resynchronisation therapy defibrillators (CRT-Ds), Fresenius Medical Care Australia’s Seep-Safe tubing systems.

CRT-Ds are implantable medical devices that deliver electrical impulses to treat abnormal heart rhythms. They can be reprogrammed using external controllers. Medtronic said it has received two reports of patients outside of Australia losing therapy in their left ventricles following a particular sequence of reprogramming commands.

The issue has been confirmed in only 0.38 percent of patients implanted with the potentially affected CRT-D devices. Medtronic has contacted cardiologists treating patients with potentially affected devices.

Read the safety alert here: www.tga.gov.au/alert/medtronic-crt-ds-various-models.

Sleep-Safe Tubing Systems

Fresenius Medical Care Australia is recalling Sleep-Safe Set, Sleep-Safe Set Plus and Sleep-Safe Set Paed patient and drainage lines manufactured before September 2016 due to leakage problems.

Overwelded coils in these products may cause them to leak, which can make it difficult to unroll the tubing and create pinholes in the lines. This damage may not be visible, will not be detected by the device itself, and can lead to infection.

Read the notice here: www.fdanews.com/12-22-16-tubing.pdf.