BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1273824 · Received December 23, 2008

    Report

    Report Number
    3006556115-2008-00681
    Event Type
    Injury
    Date Received
    December 23, 2008
    Date of Event
    September 19, 2008
    Report Date
    December 5, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT'S DEVICE HAS BEEN EXPLANTED DUE TO SUBSEQUENT INFECTION AT THE IMPLANT SITE. THE PATIENT REPORTEDLY HAD A SEROMA AT THE IMPLANT SITE AND WAS GIVEN A BIOFILM DIAGNOSIS. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS (CEFTRIAXONA, CEFALEXINA, TEICOPLANINA, AND VANCOMICINA) FOR 15 DAYS AFTER THE INITIAL INFECTION IN 2008, 15 DAYS AFTER THE FLAP SURGERY APPROXMATELY THREE MONTHS LATER, AND FOR 15 DAYS AFTER THE EXPLANT SURGERY THREE MONTHS LATER. 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 3 YR Required Intervention