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 05/20/2022

Event Type  Injury  

Event Description

Envoy medical corp.(emc) was notified on 05/20/2022 of a patient experiencing a sterile wound breakdown around the implant site.The supporting audiologist reports that the patient has had significant issues with surgical wound dehiscence and device exposure.It was determined that the system should be explanted.No incision site infection was noted or alleged.On (b)(6) 2022, the system was explanted and the ossicular chain reconstructed.Patient/clinical history with emc: (b)(6) 2011: implant; (b)(6) 2012: activation; (b)(6) 2012: fitting; (b)(6) 2012: fitting; (b)(6) 2012: fitting; (b)(6) 2013: fitting; (b)(6) 2014: fitting; (b)(6) 2016: fitting; (b)(6) 2016: battery change; (b)(6) 2019: fitting; (b)(6) 2020: fitting; (b)(6) 2021: battery change; (b)(6) 2021: fitting; (b)(6) 2021: fitting; (b)(6) 2022: explant.

Manufacturer Narrative

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

• 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: 14838729
• MDR Text Key: 295116420
• Report Number: 3004007782-2022-00007
• 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: Other
• Type of Report: Initial
• Report Date: 06/27/2022

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: 03/15/2022
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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