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

Model Number 7002, 7502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/22/2013

Event Type  Injury  

Manufacturer Narrative

This report was initially submitted to the (b)(4) on 10/21/2016 rather than the (b)(4).Issue was discovered during a remediation project in 2016.

Event Description

Explant of transducers due to rejection of foreign body.On (b)(6) 2010 - initial implant (as), (b)(4); bl pta=50 db from activation, implant report attached.On (b)(6) 2010 - activation shows normal benefit, pta=32 db; notes include exposed lead, recent ab treatment, on (b)(6) 2010- incision repair procedure (report attached); patient noted to be smoker, on (b)(6) 2010 - fitting (attached) showns normal benefit pta=31db; recurrence of infection included in notes on (b)(6) 2010 - incision repair procedure (report attached); sp removed in attempt to resolve infection, on (b)(6) 2010 - re-implant sp after infection healed (report attached), on (b)(6) 2013 - rma form received noting transducers returned due to "post-operative rejection of foreign body." (attached) (b)(6) 2016 - summary: given documented history of chronic infection and multiple attempts to resolve surgically, this is most likely a full system explant due to infection.When audiometric data was collected, all indications suggest normal device function.

• Brand Name: ESTEEM
• Type of Device: ESTEEM II SP
• Manufacturer (Section D): ENVOY MEDICAL CORP.; 4875 white bear parkway; white bear lake MN 55110
• Manufacturer Contact: todd koeppel ; 4875 white bear parkway; white bear lake, MN 55110 ; 6513618057
• MDR Report Key: 7169918
• MDR Text Key: 96587505
• Report Number: 3004007782-2016-00009
• Device Sequence Number: 1
• Product Code: OAF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P090018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/21/2016

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: 01/01/2011
• Device Model Number: 7002, 7502
• Device Catalogue Number: 907002-002, 907502-002
• Device Lot Number: EMC0002905, EMC0002906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: 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
• Patient Age: 27 YR