Device 1 of 2: ref mfr report: 1627487-2014-02419.The pt received two scs leads for the same lot number.It was reported the pt is not receiving any stimulation therapy from his scs system.The pt stated his stimulation had been intermittent.A diagnostics of the pt's system revealed all the contacts are invalid for both leads.Additional info received on (b)(6) 2014 identified the pt's scs lead were explanted and replaced.It was observed the leads appeared fractured with fluid inside the casing.In addition, it was uncertain if any fluid intruded in the pt's ipg, therefore, the physician decided to replace the pt's ipg.
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