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 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Patient was reported to be experiencing an incision-site infection and wound breakdown after sustaining trauma to the implant/incision site during an impact against furniture.Esteem ii sp was removed to promote healing.Device was returned to emc (b)(6) 2021.Device and 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 (b)(6) 2021 of a patient that experienced surgical incision site infection and dehiscense due to trauma sustained to the incision/implant site.Trauma was sustained from an impact against furniture.The lead wires were reported to be visible due to the wound breakdown.Esteem ii device was removed to allow for wound healing.Patient is being treated/monitored by physician.No device or procedureal deficiencies are alleged as the issue is related to trauma sustained at the incision site from impact against furniture.Patient/clinical history with emc: on (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).

• 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: 11267160
• MDR Text Key: 233297544
• Report Number: 3004007782-2021-00001
• 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: 02/02/2021

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: 09/24/2019
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2018
• 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