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 Unspecified Infection (1930)

Event Date 10/08/2021

Event Type  Injury  

Event Description

Envoy medical corp.(emc) quality/complaints was notified on 10/08/2021 of a patient that required a revision surgery to review potential middle ear and mastoid inflammation/infection.It was observed that the suspected infection produced inflammation and tissue growth in the middle ear and mastoid, and lead to an eroded portion of the posterior canal wall.Due to the severity of the granulation tissue, the surgeon decided it was best to proceed with a full esteem ii explant.The affected tissue was also removed.The canal wall was repaired and the ossicular chain was reconstructed successfully.Patient/clinical history with emc: (b)(6).

Manufacturer Narrative

Device was explanted and returned to emc for evaluation.Mfr records were reviewed.No device 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: 12759068
• MDR Text Key: 282638658
• Report Number: 3004007782-2021-00009
• 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: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/05/2021

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: 03/23/2018
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• 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