MAUDE Adverse Event Report: ENVOY MEDICAL CORPORATION ESTEEM; ESTEEM II, PRODUCT CODE: OAF

Model Number 2001

Device Problem Electrical Shorting (2926)

Patient Problem Hearing Impairment (1881)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Patient was experiencing feedback that is consistent with electrical feedback.The device was demonstrating feedback similar to other confirmed cases of electrical feedback and there is no reason to believe that feed back was mechanical in nature.Based on available test and diagnostic data, the source of the feed back cannot be conclusively identified as there is no visual evidence of the previously alleged header abrasion issue, known to cause electrical feedback in similar cases.Therefore no root cause could be identified for this case.

Event Description

Envoy medical corp.(emc) was notified on 05/29/2019 that a patient was experiencing low frequency feed back, with a feedback test abnormal at 250-500 hz.This low freq feedback prevented proper programming.Test results were consistent with electrical feedback.The alleged issue could not be confirmed until a battery replacement procedure could be performed and the appropriate testing could be performed to confirm efficacy of the device.Following the battery change procedure, the patient's esteem diagnostics were within range.Patient no longer experiences gain / feed back limitations and is meeting nal/rp targets and wrs is consistent with baseline.Returned device evaluation was run successfully and visual inspection shows no evidence of previously alleged header abrasion.Root cause could not be determined utilizing available analysis/test methods.Patient/clinical history with emc: (b)(6) 2014- implant.(b)(6) 2014- activation.(b)(6) 2015- fitting.(b)(6) 2015- fitting.(b)(6) 2019- clinical review.(b)(6) 2019- fitting.(b)(6) 2019- battery change.(b)(6) 2019- post battery change fitting.

• 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: 9296756
• MDR Text Key: 219781077
• Report Number: 3004007782-2019-00006
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/11/2015
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0005473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2014
• 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