BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3242917 · Received July 19, 2013

    Report

    Report Number
    3006556115-2013-00316
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY FELL AND HIT HER HEAD AT THE IMPLANT SITE APPROXIMATELY FOUR MONTHS AGO. THE PATIENT HAS REPORTED PAIN NEAR THE IMPLANT SITE AND HEADACHES. THE PATIENT'S PERFORMANCE HAS DECREASED. THE DOCTOR NOTED THAT THE PATIENT'S SKIN OVER THE IMPLANT SITE IS THIN WITH CRUSTING AND BELIEVES THE PATIENT'S DEVICE MAGNET MAY HAVE BEEN DISLODGED FROM THE FALL. THE DOCTOR HAS RECOMMENDED TO CLEANSE AND PUT ANTIBIOTIC OINTMENT (TYPE UNKNOWN) OVER THE IMPLANT SITE. THE PATIENT IS BEING MONITORED AND DEVICE TESTING WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337955 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention