BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 4122398 · Received September 18, 2014

    Report

    Report Number
    3006556115-2014-00436
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 30, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT'S DEVICE HAS BEEN EXPLANTED DUE TO SUBSEQUENT INFECTION AT THE IMPLANT SITE. THE PATIENT REPORTEDLY DEVELOPED A BIOFILM AND EDEMA, AND EXPERIENCED SWELLING AROUND THE IMPLANT. THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578937 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention