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

Model Number	2001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device passed all functional testing.No anomalies associated with sterilization of product.
Event or Problem Description
Sound processor explant due to development of seroma.Patient history: (b)(6) 2011 - patient initially implanted, (b)(6) 2011 - activation, (b)(6) 2012 - fitting, (b)(6) 2016 - battery change, (b)(6) 2016 - fitting and summary report - no indications of seroma at this visit.On (b)(6) 2018 - physician notified envoy that patient has fluctuant mass, possible abcess, on top of sound processor.Patient prescribed antibiotics.On (b)(6) 2018 - physician reported that fluctuant mass is seroma without any indications of infection.Patient has been scheduled for drainage of seroma and explant of sound processor for (b)(6) 2018.

• Brand Name: ESTEEM
• Common Device Name: ESTEEM II SYSTEM
• Manufacturer (Section D): ENVOY MEDICAL CORP.; 4875 white bear parkway; white bear lake MN 55110
• MDR Report Key: 7286241
• Report Number: 3004007782-2018-00002
• Device Sequence Number: 1054629
• Product Code: OAF
• UDI-Device Identifier: 00812282020214
• UDI-Public: 00812282020214
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P090018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/28/2017
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0005893
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR