Patient experienced sp implant site wound breakdown, caused by eyeglass temple trauma, as noted by the physician.The wound dehiscence is planned to be repaired by the physician.Device has not been returned to emc, and the issue is not related to device deficiency (no deficiency is alleged) but rather to use (eyeglass frame trauma).
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Envoy medical corp.(emc) was notified on 11/19/2019 of a sterile wound dehiscence.The physician noted that the likely cause was trauma to the skin from eye glasses.No device deficiency or infection was alleged or noted.Patient has opted for a wound repair procedure to address the issue.The procedure has not yet occured.Patient/clinical history with emc: (b)(6) 2011: implant, (b)(6) 2011: activation, (b)(6) 2011: fitting, (b)(6) 2012: fitting, (b)(6) 2014: fitting, (b)(6) 2018: fitting, (b)(6) 2018: battery change, (b)(6) 2019: emc notified of sterile wound dehiscence ( mdr 3004007782-2019-00008).
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