Envoy medical corp.(emc) was notified on (b)(6) 2022 of a patient experiencing a wound breakdown around the implant site, exposing the sp.No incision site infection was noted or alleged.On (b)(6) 2022, the esteem system was removed.Patient/clinical history with emc: 2012-04-05 implant, 2013-02-18 fitting, 2014-11-25 fitting, 2014-12-01 battery change, 2017-07-20 battery check, 2017-12-08 battery change, 2017-12-08 fitting, 2020-06-26 battery check, 2021-01-08 battery change, 2021-06-15 sp removal wound breakdown, 2022-03-03 battery change, 2022-03-08 fitting, 2022-09-23 wound breakdown and system explant.
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