BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM

    MDR report key: 3881257 · Received February 14, 2014

    Report

    Report Number
    3004007782-2014-00002
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    September 4, 2013
    Report Date
    February 13, 2014
    Manufacturer
    ENVOY MEDICAL
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH THE ESTEEM SYSTEM (B)(6) 2012. ON (B)(6) 2013 PT WAS RECEIVING A FITTING AND INDICATED THE DEVICE WAS IN CONSTANT FEEDBACK IN ALL PROFILES AND VOLUME STEPS. THE FEEDBACK SCAN INDICATED BROAD SPECTRUM (ELECTRICAL FEEDBACK. ON (B)(6) 2013 PT WENT IN FOR A LOCAL ANESTHESIA SURGERY WHICH REPLACED THE SOUND PROCESSOR (SP). ON (B)(6) 2014 THE SOUND PROCESSOR WAS RECEIVED BY ENVOY. AS DOCUMENTED IN THE ATTACHED REPORT, HE ELECTRICAL FEEDBACK WAS SHOWN TO ARISE FROM ABRASIVE DAMAGE, MOST LIKELY CAUSED BY THE SP BEING IMPROPERLY SECURED. THIS KNOWN ISSUE HAS BEEN ADDRESSED RECENTLY, WITH MITIGATING ACTIONS WHICH WERE NOT IMPLEMENTED AT THE TIME OF THE ORIGINAL IMPLANT. NO PT INJURY OTHER THAN REVISION SURGERY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97776 ESTEEM OAF ENVOY MEDICAL 2001 EMC0004661

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention