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); Post Operative Wound Infection (2446)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

Patient is experiencing wound breakdown.There is no indication of infection.Device has not been returned to emc, and production records have been reviewed.The issue does not appear to be device related but rather medically related to patient.

Event Description

Envoy medical corp.(emc) was notified on (b)(6) 2020 of an alleged wound breakdown/exposed esteem hardware issue.No infection is alleged or noted.Patient/clinical history with emc: (b)(6) 2005 - implant, (b)(6) 2008 - battery replacement, (b)(6) 2009 - 3 yr visit, (b)(6) 2012 - battery replacement, (b)(6) 2013 - fitting, (b)(6) 2016 - battery replacement, (b)(6) 2016 - fitting, (b)(6) 2016 - fitting, (b)(6) 2020 - battery check, (b)(6) 2020 - battery replacement.

Event Description

Follow-up report / additional information provided: emc was notified on (b)(6) 2021 that the patient experienced an infection in the sp implant site.Esteem ii system was explanted on (b)(6) 2021.No device or performance deficiency is alleged or noted.Issue is related to previously reported wound breakdown.Updated patient/clinical history with emc: patient/clinical history with emc: (b)(6) 2005 - implant.(b)(6) 2008 - battery replacement.(b)(6) 2009 - 3 yr visit.(b)(6) 2012 - battery replacement.(b)(6) 2013 - fitting.(b)(6) 2016 - battery replacement.(b)(6) 2016 - fitting.(b)(6) 2016 - fitting.(b)(6) 2020 - battery check.(b)(6) 2020 - battery replacement.(b)(6) 2020 - fitting.(b)(6) 2021 - battery change.(b)(6) 2021 - fitting.(b)(6) 2021 - eii system explant.Envoy medical corp.(emc) was notified on (b)(6) 2020 of an alleged wound breakdown/exposed esteem hardware issue.No infection is alleged or noted.Patient/clinical history with emc: (b)(6) 2005 - implant.(b)(6) 2008 - battery replacement.(b)(6) 2009 - 3 yr visit.(b)(6) 2012 - battery replacement.(b)(6) 2013 - fitting.(b)(6) 2016 - battery replacement.(b)(6) /2016 - fitting.(b)(6) 2016 - fitting.(b)(6) 2020 - battery check.(b)(6) 2020 - battery replacement.

Manufacturer Narrative

Emc was notified of infection in the area of sp implant.Esteem ii system explant was performed.

• 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
• MDR Report Key: 10310669
• MDR Text Key: 201664818
• Report Number: 3004007782-2020-00004
• Device Sequence Number: 1
• Product Code: OAF
• Combination Product (y/n): N
• PMA/PMN Number: P090018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

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: 03/06/2021
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention