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

Model Number 2001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 04/17/2023

Event Type  Injury  

Event Description

Patient is bilateral implantee and was seen on (b)(6) 2022 regarding thin skin around the implant area.No device extrusion was observed at that time.(b)(6) medical, was notified on (b)(6) 2023 of an extrusion of the esteem transducers.Patient was seen on (b)(6) 2023, for skin assessment and treatment recommendation.No infection was reported/alleged.The surgeon plans to explant the esteem system and implant a new system after the area has healed.Patient/clinical history with emc: (b)(6) 2008 - implant.(b)(6) 2008 - device on, (b)(6) 2008 - activation, (b)(6) 2008 - fitting, (b)(6) 2008 - fitting, (b)(6) 2011 - battery change, (b)(6) 2012 - fitting, (b)(6) 2014 - sound event and fitting, (b)(6) 2015 - fitting, (b)(6) 2015 - battery change, (b)(6) 2015 - fitting, (b)(6) 2016 - fitting, (b)(6) 2018 - fitting, (b)(6) 2018 - transmastoid revision, (b)(6) 2018 - fitting, (b)(6) 2022 - follow-up re.Thin skin and soreness.(b)(6) 2023 - follow-up re.Device extrusion, skin assessment and treatment recommendation.

• Brand Name: ESTEEM
• Type of Device: ESTEEM II SYSTEM
• 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: 16903729
• MDR Text Key: 314922467
• Report Number: 3004007782-2023-00005
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/02/2023

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: 05/31/2019
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006289
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• 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