BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1213965 · Received October 28, 2008

    Report

    Report Number
    3006556115-2008-00573
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CO WAS INFORMED THAT THE PT DEVELOPED AN INFECTION ONE WEEK AFTER INITIAL IMPLANTATION. THE PT WAS HOSPITALIZED FOR 5 DAYS. SKIN IRRITATION FROM HEADPIECE USE WAS NOT OBSERVED. THE SURGEON REQUESTED THE PT NOT USE EXTERNALS UNTIL INFECTED AREA IS HEALED. THE PT WS HOSPITALIZED AGAIN FOR 7 DAYS. THE PT WAS ON IV ANTIBIOTICS (CIPRO) FOR 4 WEEKS. SURGERY TO EXPLANT THE PT'S DEVICE IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R