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 04/17/2023

Event Type  Injury  

Event Description

Envoy medical corp.(emc) was notified on 05-apr-2023 that the patient reported not being able to hear during their post-battery change fitting.Esteem testing showed abnormal sensor output.Multiple troubleshooting attempts were made but could not resolve the issue.On (b)(6) 2023, a backed-out sensor lead was confirmed with an x-ray, and a follow-up revision procedure was done the same day to resolve the issue.Patient was seen on (b)(6) 2023, where it was confirmed that the sensor and new sp were functioning within normal bounds.Patient/clinical history with emc: (b)(6) 2012 - implant - aborted; (b)(6) 2012 - pre-op; (b)(6) 2012 - implant (right ear); (b)(6) 2013 - fitting; (b)(6) 2014 - sound event; (b)(6) 2017 - battery check; (b)(6) 2017 - battery change; (b)(6) 2023 - battery check and fitting; (b)(6) 2023 - battery change; (b)(6) 2023 - fitting; (b)(6) 2023 - revision; (b)(6) 2023 - fitting.

Manufacturer Narrative

Patient experienced a backed-out sensor 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 ; 6513618068
• MDR Report Key: 16834566
• MDR Text Key: 314270171
• Report Number: 3004007782-2023-00004
• 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
• 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: 11/30/2023
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0007060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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