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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 .
Contact Information 1800 668 670 - Medtronic Australasia Customer Service