| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00756-1 |
| Product Name/Description |
RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura Implantable Cardioverter Defibrillators (ICDs) and Assurity and Allure Pacemakers when used with Merlin@home RF Remote Monitoring Transmitter Model EX1150
All model numbers affected
ARTG Number (Merlin@home Remote Monitoring System): 161670 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
A software anomaly has been identified in the Merlin@home system that also has the potential to cause software resets for St. Jude Medical devices.
Despite the previous software upgrade, a low incidence of back up operation in some implanted St. Jude Medical devices with radio-frequency (RF) capability has been observed. This may occur as a result of a Merlin@home transmitter initiating an implanted device software reset.
This issue can only occur when the patient is being actively monitored by a Merlin@home RF bedside transmitter. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons are advised that the majority of ICD and pacemaker devices are non-invasively restored by St. Jude Medical Technical Support over the air. However, in rare cases the device is unable to be restored and replacement may be required. St. Jude Medical has refined the software download procedure to reduce the incidence of failure.
In the event a patient’s device reverts to back-up mode, St Jude Medical Australia recommends bringing the patient back in the clinic to clear the condition and return the device to full functionality.
The Merlin@home transmitter software will be updated to prevent this issue from occurring. The software update will be performed automatically over the telephone, broadband or cellular connection . |
| Contact Information |
02 9936 1215 - St Jude |