BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1133144 · Received August 22, 2008

    Report

    Report Number
    3006556115-2008-00441
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT DEVELOPED AN INFECTION. SKIN IRRITATION FROM HEADPIECE USE WAS NOT OBSERVED. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE UNKNOWN) FOR 6 WEEKS. THE INFECTION CLEARED UP. THE PATIENT CONTINUES TO BE MONITORED BY THE CENTER.

    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 Required Intervention