| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01335-1 |
| 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 |
19/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
St. Jude Medical has identified that in rare cases devices with Radio Frequency (RF) communication capability can revert to backup operation settings This issue can occur as a result of a Merlin@home transmitter initiating an implanted device software reset. This issue can only occur while the patient is being actively monitored by a Merlin@home RF bedside transmitter. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
The Merlin@home software will be updated to prevent this issue from occurring. The software update will be performed automatically over the telephone, broadband or cellular connection.
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.
Further information will be published on the TGA web site at - http://www.tga.gov.au/current-year-alerts
This action has been closed-out on 14/07/2016. |
| Contact Information |
02 9936 1215 - St. Jude Medical Australia |