Envoy medical corp.(emc) was notified on 09/10/2020 of a patient that experienced surgical incision site infection and dehiscense.Patient was treated with oral keflex prior to the sp explant procedure.At the time of the sp explant procedure, it was noted that the infection was cleared.No device deficiencies are alleged.Patient/clinical history with emc: (b)(6) 2008 initial implant, (b)(6) 2008 device on, (b)(6) 2008 activation, (b)(6) 2008 2-month, (b)(6) 2008 unscheduled, (b)(6) 2008 4-month, (b)(6) 2012 battery change, (b)(6) 2013 fitting, (b)(6) 2016 battery change, (b)(6) 2017 fitting, (b)(6) 2019 fitting, (b)(6) 2019 battery check, (b)(6) 2019 battery change, (b)(6) 2019 fitting, (b)(6) 2020 sp explant.
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