BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2850694 · Received November 20, 2012

    Report

    Report Number
    3006556115-2012-00557
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT DEVELOPED A SEROMA AND CUTANEOUS FISTULA AT THE IMPLANT SITE AFTER INITIAL IMPLANT SURGERY. THE SITE WAS TREATED AND HEALED AFTER 6 MONTHS. THE PATIENT REMAINS IMPLANTED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION; ONCE MORE INFORMATION IS OBTAINED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention