MAUDE Adverse Event Report: ENVOY MEDICAL CORPORATION ESTEEM; ESTEEM II, PRODUCT CODE: OAF

Model Number 2001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Patient was reported to be experiencing a wound breakdown.Mfr records were reviewed.No device or procedural issues were identified related to this adverse event.Patient has a history of wound dehiscence.

Event Description

Envoy medical corp.(emc) was notified on 03/08/2022 of a (b)(6) 2022 esteem explant with transition to ci.On 03/09/2022, emc received additional information/notice that the explant was related to a wound breakdown on the right side.No incision site infection was noted or alleged.No device or procedural deficiencies are alleged as the issue is noted to be likely related to patient's anatomy and history of wound dehiscence.Patient was bilaterally implanted with the esteem ii system.Patient/clinical history with emc: (b)(6) 2012 implant; (b)(6) 2013 fitting; (b)(6) 2014 wound breakdown; (b)(6) 2014 battery insertion; (b)(6) 2014 fitting; (b)(6) 2014 fitting; (b)(6) 2017 fitting; (b)(6) 2017 battery change; (b)(6) 2017 post battery change programming; (b)(6) 2019 wound breakdown battery change; (b)(6) 2020 battery removal, revision ;(b)(6) 2021 new battery, re-implant; (b)(6) 2021 revision wound repair right ear; (b)(6) 2022 explant (right side).

• Brand Name: ESTEEM
• Type of Device: ESTEEM II, PRODUCT CODE: OAF
• Manufacturer (Section D): ENVOY MEDICAL CORPORATION; 4875 white bear parkway; white bear lake MN 55110
• Manufacturer (Section G): ENVOY MEDICAL CORPORATION; 4875 white bear parkway; white bear lake MN 55110 8057
• Manufacturer Contact: maksim trofimovich ; 4875 white bear parkway; white bear lake, MN 55110-8057 ; 6513618029
• MDR Report Key: 13863384
• MDR Text Key: 293154277
• Report Number: 3004007782-2022-00004
• Device Sequence Number: 1
• Product Code: OAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/06/2021
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention