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 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Patient is experiencing wound breakdown that is similar to that seen in previous instance of wound breakdown for this patient.Device has not been returned to emc, and the issue does not appear to be device related but rather medically related to patient.

Event Description

Envoy medical corp.(emc) was notified on (b)(6) 2019 of a battery change that occured for a patient that was experiencing an alleged wound breakdown/exposed sp hardware issue.Battery was replaced per standard procedure and the wound was closed.No infection was found/noted.Patient has previous history of wound breakdown.Patient/clinical history with emc: on (b)(6) 2012: initial implant.On (b)(6) 2013: fitting.On (b)(6) 2014: wound breakdown.On (b)(6) 2014: battery insertion.On (b)(6) 2014: fitting.On (b)(6) 2014: fitting.On (b)(6) 2017: fitting.On (b)(6) 2017: battery change.On (b)(6) 2017: post battery change programming.On (b)(6) 2019: battery change (due to wound breakdown).

• 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: 8696072
• MDR Text Key: 148146176
• Report Number: 3004007782-2019-00003
• 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: 06/13/2019

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: 10/24/2017
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0005991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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