Device 3 of 5.Reference mfr.Report:1627487-2015-03513, 1627487-2016-03514, 1627487-2016-01306, & 1627487-2016-01307.Additional information received identified the scs extensions (device 2 &3) are from the same lot.It was also reported the issue was resolved with the explant and replacement of the ipg and extensions.As a result, surgical intervention regarding the scs leads will be taken at a later date to address the issue.The scs leads (both devices have (b)(4) serial numbers) are being reported as device 4 and device 5 respectively.
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