Envoy medical corp.(emc) was notified on (b)(6) 2022 of a patient experiencing a sterile wound breakdown around the implant site, exposing the sp.The surgeon reports that the patient has thin skin, contributed by the patient's age.This contributed to the exposure of the device.No incision site infection was noted or alleged.On (b)(6) 2022, the esteem sp was removed to allow for incision site healing.Patient/clinical history with emc: (b)(6) 2011 implant, (b)(6) 2011 activation, (b)(6) 2012 fitting, (b)(6) 2017 battery change, (b)(6) 2017 battery change, (b)(6) 2022 fitting, (b)(6) 2022 removal of sp.
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