BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1760706 · Received July 12, 2010

    Report

    Report Number
    3006556115-2010-00323
    Event Type
    Injury
    Date Received
    July 12, 2010
    Date of Event
    August 19, 2009
    Report Date
    June 21, 2010
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY HAD A LEGION AROUND THE IMPLANT SITE. SURGERY TO REMOVE NONVIABLE SURROUNDING TISSUE AND TO WASH THE AREA WITH ANTIBIOTIC SOLUTION (TYPE UNK) WAS PERFORMED. THE PT'S IMPLANT IS CURRENTLY EXTRUDING WITHOUT SIGNS OF INFECTION. SURGERY TO EXPLANT PT'S DEVICE IS BEING DISCUSSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention