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 09/14/2021

Event Type  Injury  

Event Description

Envoy medical corp.(emc) was notified on 09/14/2021 by an esteem ii surgeon of a patient that experienced surgical incision site dehiscense and infection.The surgeon stated that the patient was able to see the leads through the wound breakdown.The patient had a battery change (b)(6) 2021.Patient stated preference to keep the implant.The patient was seen for a revision surgery on (b)(6) 2021.On (b)(6) 2021 the surgeon updated emc fce br, indicating that the patient can hear from the implant post-revision.Implant had rotated with leads out of normal position superiorly.Surgeon cleaned everything and completely revised the closure.The surgeon expressed confidence in the chances of successful wound healing.Patient/clinical history with emc: (b)(6).

Manufacturer Narrative

Device was not explanted or returned to emc for evaluation.Mfr records were reviewed.No device 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
• MDR Report Key: 12633477
• MDR Text Key: 281671704
• Report Number: 3004007782-2021-00008
• Device Sequence Number: 1
• Product Code: OAF
• Combination Product (y/n): N
• PMA/PMN Number: P090018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/14/2021

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: EMC0006721
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention