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

Model Number	2001
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Partial Hearing Loss (4472)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient required a revision surgery to correct a potentially backed-out driver lead.Lead retraction not confirmed, but conservatively reported out of caution.The patient's hearing was restored after the sp was replaced.Mfr records were reviewed on 13-may-2025.No issues were observed.
Event or Problem Description
Envoy medical corp.(emc) was notified on 25-apr-2025 that the patient had undergone a revision on (b)(6) 2025 to address limited benefit from the device and intermittency following a routine battery change on (b)(6) 2025.During the revision, the surgeon noted that the driver lead may have been partially inserted in the header port.Lead retraction not confirmed, but conservatively reported out of caution.Surgeon replaced the sound processor, and patient confirmed hearing shortly after surgery.Patient/clinical history with emc: on (b)(6) 2011: implant, on (b)(6) 2011: activation, on (b)(6) 2012: fitting, on (b)(6) 2012: enhancement, on (b)(6) 2012: fitting, on (b)(6) 2012: analysis, on (b)(6) 2012: fitting, on (b)(6) 2013: fitting, on (b)(6) 2013: fitting, on (b)(6) 2015: fitting, on (b)(6) 2016: battery change, on (b)(6) 2016: fitting and remote support, on (b)(6) 2018: fitting and remote support, on (b)(6) 2021: battery change, on (b)(6) 2023: fitting, on (b)(6) 2025: battery change, on (b)(6) 2025: post-battery change/pre-op testing, on (b)(6) 2025: revision.

• Brand Name: ESTEEM
• Common Device Name: ESTEEM II SOUND PROCESSOR
• Manufacturer (Section D): ENVOY MEDICAL CORP.; 4875 white bear parkway; white bear lake MN 55110
• Manufacturer (Section G): 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: 22014196
• Report Number: 3004007782-2025-00005
• Device Sequence Number: 7984988
• Product Code: OAF
• UDI-Device Identifier: 00812282020214
• UDI-Public: (01)00812282020214(11)241014(17)251014(10)EMC0007674
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P090018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/14/2025
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0007674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown