BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1883809 · Received October 20, 2010

    Report

    Report Number
    3006556115-2010-00515
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THERE WAS DRAINAGE AT THE PT'S IMPLANT SITE. THE PT'S INTERNAL DEVICE WAS EXPLANTED DUE TO INFECTION. THE PT ALSO HAD A HEMATOMA THAT WAS DRAINED. THE PT HAS A MEDICAL HISTORY OF ANTICOAGULATION THERAPY AND THIN SKIN FLAP. THERE ARE NO PLANS TO REIMPLANT DUE TO DIFFICULTIES WITH SKIN FLAP ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention