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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00531-1
Product Name/Description	Axium Neurostimulator Leads (MN20450-50AU, MN20450-90AU) KIT IMPLANT LEAD 50CM Model MN20450-50AU KIT IMPLANT LEAD 90CM Model MN20450-90AU ARTG number: 202325
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	23/05/2014
Responsible Entity	Spinal Modulation Pty Ltd
Reason/Issue	Over 2000 DRG leads have been implanted in patients worldwide. At this time, there have been 10 reports of lead breakage during attempted lead removal, resulting in lead fragments remaining implanted in the patient. To date, there have not been any reported complications or long-term sequelae surrounding these events. During lead removal of a permanently implanted lead, the Spinal Modulation implant instructions and warnings must be followed to help prevent lead breakage.
Recall Action	Recall for Product Correction
Recall Action Instructions	Spinal Modulation is undertaking this action to provide additional information and clarify the steps necessary to ensure safe lead removal after permanent implantation. Some of these methods are described in the “Physician Implant Manual". The additional information that has already been identified in the letter will be included in the future releases of the Physician Implant Manual.
Contact Information	03 9225 5265 - Spinal Modulation