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 04/28/2021

Event Type  Injury  

Manufacturer Narrative

Patient experienced sterile wound breakdown.Patient opted for wound repair and re-implant.No system or device deficiency was alleged or noted.No infection was found or noted during revision procedure or prior.Review of manufacturing records shows no deviations or issues related to manufacturing.Issues appears to be related to anatomy.

Event Description

Envoy medical corp.(emc) was notified on 04/28/2021 of a wound breakdown issue.No infection was alleged and no discharge was observed (or noted during the revision procedure).The patient required a wound repair revision procedure (date of revision procedure (b)(6) 2021) with temporalis muscle/temporoparietal fascia flap, split thickness skin graft and replacement of the esteem sound processor (replacement of the sound processor is routine as the device is not reuseable).Returned product sound processor testing data is not related to the reported issue, as the complaint is related to wound breakdown and not device/system function/performance.Manufacturing record review shows no anamolies or issues related to the complaint.Patient/clinical history with emc: (b)(4).

• 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: 11885278
• MDR Text Key: 266506316
• Report Number: 3004007782-2021-00003
• 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: Replace
• Type of Report: Initial
• Report Date: 05/25/2021

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: EMC0006603
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• 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