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 Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

Patient was reported to be experiencing a wound breakdown and evidence of infection.The issue is noted to be related to complications from cancer/treatment of cancer.The esteem ii system was explanted.Mfr records were reviewed.No device or procedural issues were identified related to this adverse event.

Event Description

Envoy medical corp.(emc) was notified on 02/22/2021 of an esteem ii system explant.The explant was related to surgical incision site dehiscense and evidence of site infection.The wound breakdown is noted to be related to complications from cancer.No device or procedural deficiencies are alleged as the issue is noted to be related to complications from cancer/treatment.Patient/clinical history with emc: (b)(6) 2009 - implant.(b)(6) 2009 - turn on.(b)(6) 2009- activation.(b)(6) 2009 - 2 month.(b)(6) 2009 - fitting.(b)(6) 2009 - fitting.(b)(6) 2009 - fitting.(b)(6) 2010 - fitting.(b)(6) 2010 - fitting.(b)(6) 2015 - battery replacement.(b)(6) 2021 - explant (this mdr).

• 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: 11485910
• MDR Text Key: 250083464
• Report Number: 3004007782-2021-00002
• 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: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/15/2021

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: 01/30/2016
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0005601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2015
• 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