Neuromodulation Leads Reliability Assessment in Therapy System (神经调节治疗系统的可靠性评价)

Mingxiao Jiang
Dr. Jiang received his B.S. in Engineering Mechanics from Zhejiang University, China, M.S. in Reliability Engineering from University of Arizona, and Ph.D. in Mechanics of Materials from Georgia Institute of Technology. He is currently working as a Senior Principal Reliability Engineer at Medtronic Neuromodulation. He is a CRE, a senior member of ASQ and a senior member of IEEE. He has been more


An implantable therapy system consists of multiple medical devices. When evaluating reliability of a certain device, the contribution of the device reliability to therapy system reliability should be considered. The impacts of the device failures on patients are also very important to be assessed. In this paper, we briefly describe an implantable medical therapy system – a Neuromodulation therapy system. Focus will be on Neuromodulation lead, which is one of the key devices in the therapy delivery system. A major failure mode of the lead is studied with material assessment. The resulting lead reliability behavior is further studied. Then the lead reliability is assessed at the therapy system level.

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