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 01/13/2023

Event Type  Injury  

Manufacturer Narrative

Patient was reported to be experiencing a sterile wound breakdown.Mfr records were reviewed.See attached.No device or procedural issues were identified related to this adverse event.

Event Description

The patient recently had a battery change on (b)(6) 2022.Envoy medical corp.(emc) was notified by the implanting surgery center on 13 jan 2023 of a sterile wound breakdown over the esteem ii implant site.The esteem sound processor was removed at this time to promote healing of the incision site.No infection was reported/alleged.The surgeon and patient are planning to implant a new sound processor in the near future after incision site has healed.Patient/clinical history with emc: (b)(6) 2011 implant, (b)(6) 2011 turn on, (b)(6) 2011 fitting, (b)(6) 2011 fitting, (b)(6) 2011 enhancement, (b)(6) 2012 fitting, (b)(6) 2012 fitting, (b)(6) 2013 fitting, (b)(6) 2013 fitting, (b)(6) 2013 fitting, (b)(6) 2014 audiology, (b)(6) 2014 fitting, (b)(6) 2014 fitting, (b)(6) 2016 fitting, (b)(6) 2017 fitting, (b)(6) 2017 battery change, (b)(6) 2017 fitting, (b)(6) 2017 xray, (b)(6) 2017 transmastoid revision, (b)(6) 2017 fitting, (b)(6) 2019 fitting, (b)(6) 2022 battery change, (b)(6) 2022 sp sn (b)(4) explant (this emdr, 3004007782-2023-00001).

• 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: 16467819
• MDR Text Key: 310523613
• Report Number: 3004007782-2023-00001
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/20/2023
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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; Other