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

Model Number 2001

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

Patient Problem Wound Dehiscence (1154)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

Patient was reported to be experiencing a wound breakdown.Mfr records were reviewed.See attached.No device or procedural issues were identified related to this adverse event.

Event Description

Envoy medical corp.(emc) was notified on (b)(6) 2022 of an ous patient experiencing a wound breakdown around the implant incision site.Patient has contacted surgeon for further advise.No incision site infection was noted or alleged.Patient/clinical history with emc: (b)(6) 2010 implant, (b)(6) 2010 turn on, (b)(6) 2010 fitting, (b)(6) 2010 fitting, (b)(6) 2011 fitting, (b)(6) 2011 fitting, (b)(6) 2012 fitting, (b)(6) 2014 fitting, (b)(6) 2015 battery replacement, (b)(6) 2022 battery replacement.

Manufacturer Narrative

Follow-up(1): patient is experiencing a secondary sterile wound breakdown, after the plastic surgery repair of the original wound breakdown.The patient has known underlying health conditions and is taking medications for those conditions, including blood thinning medication.Patient was reported to be experiencing a wound breakdown.Mfr records were reviewed.See attached.No device or procedural issues were identified related to this adverse event.

Event Description

Follow-up(1): envoy medical corp.(emc) was notified on 12/05/2022 of patient experiencing a secondary wound breakdown at the implant incision site.No infection is reported.This secondary breakdown occurred after wound repair from the first wound breakdown reported on 3004007782-2022-00009.No components of the esteem system were removed at the time.The wound repair was plastic surgery.The patient is reported to have underlying medical conditions and to be taking medication, including blood thinning medication.The patient has elected to have the esteem ii system explanted.The explant has not occurred at the time of this report.Envoy medical corp.(emc) was notified on 08/31/2022 of an ous patient experiencing a wound breakdown around the implant incision site.Patient has contacted surgeon for further advise.No incision site infection was noted or alleged.Patient/clinical history with emc: date: (b)(6) 2010, note: implant.Date: (b)(6) 2010, note: turn on.Date: (b)(6) 2010, note: fitting.Date: (b)(6) 2010, note: fitting.Date: (b)(6) 2011, note: fitting.Date: (b)(6) 2011, note: fitting.Date: (b)(6) 2012, note: fitting.Date: (b)(6) 2014, note: fitting.Date: (b)(6) 2015, note: battery replacement.Date: (b)(6) 2022, note: battery replacement.

• 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: 15418855
• MDR Text Key: 299870785
• Report Number: 3004007782-2022-00009
• 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,Followup
• Report Date: 12/21/2022

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: 11/09/2022
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006839
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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): Other