MAUDE Adverse Event Report: ENVOY MEDICAL CORP. ESTEEM; ESTEEM II

Model Number 2001

Device Problems Electrical /Electronic Property Problem (1198); Low impedance (2285)

Patient Problem Hearing Impairment (1881)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

This report was initially submitted to the (b)(4) environment on 09/15/2015 rather than the (b)(4) environment.

Event Description

Pt was implanted with the esteem system (b)(6) 2012.Patient was activated on (b)(6) 2012 with satisfactory results.Patient had fitting on (b)(6) 2012 with satisfactory results.Patient had fitting on (b)(6) 2012 to reduce gain with satisfactory results.Patient had fitting on (b)(6) 2013 due to ear popping and other sounds with satisfactory results.Patient had fitting on (b)(6) 2014 due to feedback issues.Limited adjustments were made to reduce feedback patient had fitting on (b)(6) 2014 due to feedback issues and ear popping.Adjustment options were again limited due to feedback.Me issues and allergies believed to be cause of popping.Patient contacted envoy medical on (b)(6) 2015 to complain of ongoing feedback issues.On (b)(6) 2015 the esteem ii sp was explanted and replaced with another device with successful results.Sp was received by envoy on (b)(6) 2015.No pt injury other than revision surgery resulted.

• Brand Name: ESTEEM
• Type of Device: ESTEEM II
• Manufacturer (Section D): ENVOY MEDICAL CORP.; 5000 township parkway; st. paul MN 55110
• Manufacturer Contact: todd koeppel ; 5000 township parkway; st. paul, MN 55110 ; 6513618057
• MDR Report Key: 7177209
• MDR Text Key: 96856345
• Report Number: 3004007782-2015-00017
• 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,study
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/16/2012
• Device Model Number: 2001
• Device Catalogue Number: 902001-002
• Device Lot Number: EMC0004566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2011
• 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