Envoy medical corp.(emc) was notified on (b)(6) 2022 of a patient experiencing what appears to be sound intermittency ("on/off").Gentle physical manipulation around the implant site seems to affect the intermittency.On (b)(6)2022 emc received confirmation of a backed-out transduer lead, driver.Confirmation was made via lateral skull film.The resulting film appears to show a backed-out lead.The patient's last procedure was a battery change occuring (b)(6)2022.Patient/clinical history with emc: 110714 111-0073(a0) wi-st implant, 110907 111-0073(a0) wi-st activation, 110929 111-0073(a0) wi-st fitting, 111025 111-0073(a0) wi-st explant, 120315 111-0073(c0) wi-st implant, 120430 111-0073(c0) wi-st activation, 120606 111-0073(c0) wi-st fitting, 130130 111-0073 wi-st fitting, 131218 111-0073 wi_st fitting, 140814 111-0073 wi-st fitting, 170614 111-0073 wi-st battery change, 170614 111-0073 wi-st post battery change fitting and audiogram, 220204 111-0073 wi-st battery change, 220204 111-0073 wi-st post battery change fitting,and 220215 111-0073 wist intermittency complaint.
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