| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01119-1 |
| Product Name/Description |
Eon/Eon C/ Eon Mini/ Prodigy Neurostimulation Systems and Octrode/ Quattrode Percutaneous Leads and Accessories
Eon Neurostimulation System – ARTG 127126
Eon C Neurostimulation System – ARTG 158502
Eon Mini Neurostimulation System – ARTG 154912
Prodigy device - currently is supplied in Australia under the Special Access Scheme (SAS)
Octrode Percutaneous Leads - ARTG 132097
Quattrode Percutaneous Leads – ARTG 131944 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
The indication for St. Jude Medical’s (SJM) occipital nerve stimulation (ONS) therapy for the treatment of intractable chronic migraine is being removed from the product instructions for use. The post market clinical follow up data was not appropriate to demonstrate that the benefit of the therapy outweighs the risk at this time. St. Jude Medical has advised doctors not to use the Eon, Eon C, Eon Mini and Prodigy SCS devices and associated programmers, as well as the Octrode and Quattrode leads, for the purpose of occipital nerve stimulation. Please note that these products are still available for use as an aid in the management of chronic, intractable pain of the trunk and/or limbs. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
St. Jude Medical has undertaken this action not following the Uniform Recall Procedure for Therapeutic Goods (URPTG) since they have classified this as a product notification.
The TGA has classified this change as a hazard alert to inform consumers and health professionals of the changed advice relating to St Jude Medical’s occipital nerve stimulation devices and the latest data relating to their use.
Regarding patients who have already been treated for ONS therapy, St Jude Medical is not recommending a change in the way currently implanted patients are followed up.
For more information, please see http://www.tga.gov.au/alert/st-jude-medical-implantable-neurostimulators-and-accessories-various-devices . |
| Contact Information |
02 9936 1200 - St. Jude Medical Australia |