MAUDE Adverse Event Report: ENVOY MEDICAL CORPORATION ESTEEM; ESTEEM II, PRODUCT CODE: OAF

Model Number 2001

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem Partial Hearing Loss (4472)

Event Date 03/09/2023

Event Type  Injury  

Event Description

Envoy medical corp.(emc) was notified on (b)(6) 2023 of a patient reporting not being able to turn on esteem.Troubleshooting multiple successful queries but the patient reported vaint confirmation tones and struggled with hearing.On (b)(6) 2023 it was confirmed that all diagnostics were normal aside from the envoygram testing.A backed-out driver lead was confirmed via xray (partial backout).Patient/clinical history with emc: (b)(6) 2011: implant (b)(6) 2011: activation: (b)(6) 2012: fitting: (b)(6) 2017: battery change: (b)(6) 2022: battery change: (b)(6) 2022: fitting: (b)(6) 2022: sp removal: (b)(6) 2023: sp implant: (b)(6) 2023.Fitting: (b)(6) 2023: fitting.

Manufacturer Narrative

Patient experienced a backed-out driver lead after a routine battery replacement.This will require a follow-up surgery to remedy the situation.Mfr records were reviewed.No issues were identified in the mfr records.

• 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: 16701504
• MDR Text Key: 312885211
• Report Number: 3004007782-2023-00002
• 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: Other
• Type of Report: Initial
• Report Date: 03/17/2023

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?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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