BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 4142547 · Received October 1, 2014

    Report

    Report Number
    3006556115-2014-00483
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER WAS INFORMED THAT THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID LEAK DURING INITIAL IMPLANTATION. THE CSF LEAK WAS REPAIRED WITH BONE WAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611564 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1500-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention