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 04/28/2022

Event Type  Injury  

Event Description

Envoy medical corp.(emc) was notified on 04/28/2022 by the surgeon of an alleged wound breakdown over the esteem ii implant site.On (b)(6) 2022 the surgeon confirmed the wound breakdown, removed the sp and debrided the incision edges.No incision site infection was noted or alleged.The surgeon plans to re-implant an sp in four to six months.Patient/clinical history with emc: (b)(6) 2013: implant.(b)(6) 2013: fitting.(b)(6) 2017: battery replacement.(b)(6) 2022: battery replacement.

Manufacturer Narrative

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

• 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: 14409808
• MDR Text Key: 294660821
• Report Number: 3004007782-2022-00006
• Device Sequence Number: 1
• Product Code: OAF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other
• Type of Report: Initial
• Report Date: 05/16/2022

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: EMC0006840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/16/2022
• 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): Required Intervention