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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00288-1
Product Name/Description	Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient Programmers Multiple model numbers affected ARTG Numbers: 141860, 154866, 141861, 177594, 215751, 215748, 215749, 215750, 143034, 141857, 137079, 123240, 123242, 137080, 123241, 123243, 214838, 214839, 137348, 143035, 141858, 114947, 119320, 163895, 148397, 219258, 219259, 134080, 137439, 139649, 177036 and 214421
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	12/03/2014
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Post market review by Medtronic has identified that there is the potential for patients to experience spinal cord compression weeks to years after implant of a spinal cord stimulation lead. Spinal cord compression can lead to neurological deficit due to the formation of reactive tissue, sometimes with an inflammatory component. The time to onset for spinal cord compression ranges from weeks to over 17 years, and may progress after lead removal.
Recall Action	Hazard Alert
Recall Action Instructions	Medtronic is advising surgeons that prophylactic removal of the leads is not recommended. Awareness of this adverse event can lead to early detection and prevention of permanent neurological impairment. If a patient presents with new neurological deficit, spinal cord compression due to reactive tissue mass formation should be considered as a potential cause. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-spinal-cord-140317.htm .
Contact Information	1800 668 670 - Medtronic Australasia Customer Service