BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES90K IMPLANT

    MDR report key: 2980494 · Received February 22, 2013

    Report

    Report Number
    3006556115-2013-00061
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    February 2, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT EXPERIENCED A MIDDLE EAR INFECTION THAT CAUSED ELECTRODE MIGRATION AND PERFORATED THE EAR DRUM TO THE EAR CANAL. THE SURGEON REPORTEDLY PERFORMED A MASTOIDECTOMY AND MASTOIDPLASTIA, CLEANED THE MIDDLE EAR INFECTION AND REINSERTED THE MIGRATED ELECTRODE ARRAY ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77271 HIRES90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention