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 Problems Wound Dehiscence (1154); Post Traumatic Wound Infection (2447)

Event Date 08/30/2023

Event Type  Injury  

Event Description

Envoy medical corp.(emc) was notified on july 14, 2023 of an extrusion that occurred in 2018, which the esteem surgeon resolved with a rotational flap.There are no records showing that this issue was ever reported to envoy at the time of the event.On july 24, 2023, the site followed up to report that the extrusion of the esteem transducers had re-occurred, and attributed the cause to the patient's thin skin, causing the wires to become exposed over time.The esteem surgeon plans to explant the device with ossicular chain reconstruction.Patient/clinical history with emc: (b)(6) 2012 - implant.(b)(6) 2012 - activation.(b)(6) 2012 - fitting.(b)(6) 2012 - fitting.(b)(6) 2013 - fitting.(b)(6) 2013 - fitting.(b)(6) 2014 - fitting.(b)(6) 2015 - fitting.(b)(6) 2016 - fitting and remote support.(b)(6) 2018 - battery change.(b)(6) 2018 - post battery change fitting.(b)(6) 2018 - fitting and remote support.(b)(6) 2018 - fitting and clinical support.

Event Description

Follow-up (1): envoy medical corp.(emc) was notified on (b)(6) 2023 that the patient had an explant and chain re-construction.On (b)(6) 2023, the explanting surgeon confirmed that cultures were positive for pseudomonas infection in the open wound.Envoy medical corp.(emc) was notified on (b)(6) 2023 of an extrusion that occurred in 2018, which the esteem surgeon resolved with a rotational flap.There are no records showing that this issue was ever reported to envoy at the time of the event.On (b)(6) 2023, the site followed up to report that the extrusion of the esteem transducers had re-occurred, and attributed the cause to the patient's thin skin, causing the wires to become exposed over time.The esteem surgeon plans to explant the device with ossicular chain reconstruction.On (b)(6) , the surgeon reported that no infection was confirmed at that time.Patient/clinical history with emc: on (b)(6) 2012 implant.On (b)(6) 2012 activation.On (b)(6)2012 fitting.On (b)(6) 2012 fitting.On (b)(6) 2013 fitting.On (b)(6) 2013 fitting.On (b)(6) 2014 fitting.On (b)(6) 2015 fitting.On (b)(6) 2016 fitting and remote support.On (b)(6) 2018 battery change.On (b)(6)2018 post battery change fitting on (b)(6) 2018 fitting and remote support.On (b)(6) 2018 fitting and clinical support.

• 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 (Section G): 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 ; 6513618000
• MDR Report Key: 17430792
• MDR Text Key: 320173943
• Report Number: 3004007782-2023-00007
• 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,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

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: 07/31/2018
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• 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