PRA number
2020/18556
Published date
Product description
MyCareLink Relay Home Communicator
Product code: 24960
All serial numbers
The MyCareLink Relay Home Communicator sends data from an implanted heart device to medical clinicians.
ARTG 313825
(Medtronic Australasia Pty Ltd - Cardiac pulse generator reader, home-use)
Product code: 24960
All serial numbers
The MyCareLink Relay Home Communicator sends data from an implanted heart device to medical clinicians.
ARTG 313825
(Medtronic Australasia Pty Ltd - Cardiac pulse generator reader, home-use)
What are the defects?
A software update on 17 July 2020 caused a data connectivity disruption to the MyCarelink software. As a result data transmissions, including CareAlerts, are disabled between the Communicator and the CareLink Network.
This issue results in the inability for a Relay communicator to transmit implanted device data to the CareLink Network and persists until the Relay is power cycled for any reason.
There is no impact to users implanted device or data from that device.
This issue results in the inability for a Relay communicator to transmit implanted device data to the CareLink Network and persists until the Relay is power cycled for any reason.
There is no impact to users implanted device or data from that device.
What are the hazards?
If incomplete or misleading information is used to make treatment decisions this may lead to insufficient/inappropriate medical intervention causing serious health implications.
What should consumers do?
Medtronic will contact affected users in writing, by phone and by automated call messages, where Medtronic network logs indicate a lack of connectivity after July 17, 2020.
Consumers are instructed to power cycle the monitor to update the communication protocols. If the user has already completed a power cycle after July 17 they do not need to take any action.
For further information, please contact Medtronic Customer Service by phone on 1800 644 128.
Consumers are instructed to power cycle the monitor to update the communication protocols. If the user has already completed a power cycle after July 17 they do not need to take any action.
For further information, please contact Medtronic Customer Service by phone on 1800 644 128.
Supplier
Where the product was sold
International
New South Wales
Queensland
South Australia
Victoria
Western Australia
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.