MAUDE Adverse Event Report: ENVOY MEDICAL CORP. ESTEEM; ESTEEM II SP

Model Number 2001

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem Partial Hearing Loss (4472)

Event Date 04/07/2023

Event Type  Injury  

Event Description

Envoy medical corp.(emc) was notified on 07-apr-2023 that the patient was not hearing well after the post-battery change programming.Esteem testing showed abnormal driver results, which indicated a driver issue.A revision was done the same day on (b)(6) 2023, where the cause was confirmed to be a backed-out driver lead.Patient/clinical history with emc: (b)(6) 2006 : implant.(b)(6) 2006 : activation.(b)(6) 2009 : battery change.(b)(6) 2014 : fitting.(b)(6) 2014 : fitting.(b)(6) 2016 : battery change.(b)(6) 2019 : fitting.(b)(6) 2023 : battery change, fitting, and revision.

Manufacturer Narrative

Patient experienced a backed-out driver lead after a routine battery replacement.This required a follow-up surgery to evaluate and eventually replace the sp.The patient's hearing was restored after the sp was replaced.Mfr records were reviewed on 25apr2023, device was evaluated on 25apr2023.No issues were observed.

• Brand Name: ESTEEM
• Type of Device: ESTEEM II SP
• Manufacturer (Section D): ENVOY MEDICAL CORP.; 4875 white bear parkway; white bear lake MN 55110
• Manufacturer Contact: bonnie miller ; 4875 white bear parkway; white bear lake, MN 55110 ; 6513618000
• MDR Report Key: 16834558
• MDR Text Key: 314268316
• Report Number: 3004007782-2023-00003
• 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: Replace
• Type of Report: Initial
• Report Date: 04/27/2023

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: 01/09/2024
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0007080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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