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 03/21/2022

Event Type  Injury  

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.

Event Description

Envoy medical corp.(emc) was notified on 03/21/2022 by the patient of an alleged wound breakdown over the esteem ii implant site.No incision site infection was noted or alleged.On (b)(6) 2022, the wound breakdown was confirmed by the physician, including confirmation of no infection.The physician stated that the only option at this time is for full explant.Patient/clinical history with emc: (b)(6) 2005: implant, (b)(6) 2008: battery change, (b)(6) 2014: fitting, (b)(6) 2014: battery change, (b)(6) 2021: revision, (b)(6) 2022: explant (left).

• 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: 14144248
• MDR Text Key: 293558300
• Report Number: 3004007782-2022-00005
• 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: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• 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: EMC0006721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Date Manufacturer Received: 03/21/2022
• 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