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 Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Patient was reported to be experiencing a wound breakdown and evidence of secondary infection.The esteem ii sp was explanted.Mfr records were reviewed.See attached.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 (b)(6) 2021 of an esteem ii system sp explant.Left ear.The sp explant was related to surgical incision site dehiscense and evidence of site infection.The infection at the incision site is noted to likely be secondary to the wound dehiscense.No device or procedural deficiencies are alleged as the issue is noted to be likely related to patient's anatomy and history of wound dehiscense.Patient is bilaterally implanted with the esteem ii system.Patient/clinical history with emc: (b)(6) 2012 implant.(b)(6) 2013 fitting.(b)(6) 2014 fitting.(b)(6) 2012 battery change & return.(b)(6) 2017 battery check.(b)(6) 2017 battery change.(b)(6) 2017 post battery change fitting.(b)(6) 2019 fitting sheet.(b)(6) 2020 battery check.(b)(6) 2021 battery change.(b)(6) 2021 emc aware of wound breakdown (mdr 3004007782-2021-00004).(b)(6) 2021 sp removed for wound healing.

• 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: 12128065
• MDR Text Key: 260254688
• Report Number: 3004007782-2021-00004
• 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,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• 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: EMC0006603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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