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 Post Operative Wound Infection (2446)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Patient was reported to be experiencing an incision-site infection and wound breakdown after the last sp implant procedure (last procedure occurred (b)(6) 2021).It is suspected by the surgeon that the transducer leads became contaminated from the previous sp implant procedure ( (b)(6) 2021), causing this latest instance of infection/wound breakdown (reported to emc (b)(6) 2021).Device was returned to emc (b)(6) 2021.Mfr records were reviewed.No device issues were identified related to this adverse event.

Event Description

Envoy medical corp.(emc) was notified on 07/30/2021 of a patient that experienced surgical incision site infection and dehiscence.Patient has a history of wound breakdowns/infection.The surgeon stated that it is likely the implant components that were not removed (transducers/leads) during the last procedure became contaminated during the last procedure and led to this instance of infection/wound breakdown.On (b)(6) 2021 the esteem ii system was fully removed with o chain reconstruction using titanium prosthesis.The patient will be monitored/treated by the physician.Patient/clinical history with emc: (b)(6) 2012 : implant (b)(6) 2012 : fitting (b)(6) 2013 : fitting (b)(6) 2015 : battery change (b)(6) 2015 : fitting (b)(6) 2019 : battery change (b)(6) 2021 : sp removal (sp removed to allow for wound healing, mdr 3004007782-2021-00001), (b)(6) 2021 : sp implant after wound healing (b)(6) 2021 : esteem ii system explant due to infection/wound breakdown.

• 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: 12325330
• MDR Text Key: 266687239
• Report Number: 3004007782-2021-00006
• 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: health professional
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 08/16/2021

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: 03/15/2022
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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): Required Intervention