BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM

    MDR report key: 7123650 · Received December 15, 2017

    Report

    Report Number
    3004007782-2016-00006
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    June 7, 2016
    Report Date
    July 7, 2016
    Manufacturer
    ENVOY MEDICAL CORP.
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STERILE WOUND DEHISCENCE. WOUND DEHISCENCE WAS SURGICALLY REPAIRED ON (B)(6) 2016. SOUND PROCESSOR, MODEL 902001, SERIAL NUMBER (B)(4), WAS REPLACED AFTER BECOMING EXPOSED DUE TO A DEHISCENCE OF THE INCISION. A NEW SOUND PROCESSOR, SN (B)(4), WAS IMPLANTED DURING THE REPAIR SURGERY. PATIENT HAD UNDERGONE A BATTERY CHANGE PROCEDURE ON (B)(6) 2016, AND THE INCISION FROM THAT PROCEDURE DID NOT HEAL PROPERLY. PATIENT HISTORY: (B)(6) 2008 - INITIAL IMPLANT, (B)(6) 2008 - DEVICE TURNED ON, (B)(6) 2008 - ACTIVATION, (B)(6) 2008 - UNSCHEDULED FITTING, (B)(6) 2008 - 2-MONTH FOLLOWUP, (B)(6) 2008 - UNSCHEDULED FITTING, (B)(6) 2008 - UNSCHEDULED FITTING, (B)(6) 2008 - 4-MONTH FOLLOWUP, (B)(6) 2008 - UNSCHEDULED FITTING, (B)(6) 2009 - 10-MONTH FOLLOWUP, (B)(6) 2012 - BATTERY CHANGE, (B)(6) 2016 - BATTERY CHANGE, (B)(6) 2016 - WOUND DEHISCENCE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902323 ESTEEM ESTEEM II SP OAF ENVOY MEDICAL CORP. 2001 EMC0005871

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention