BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3913276 · Received June 11, 2014

    Report

    Report Number
    3006556115-2014-00289
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    February 4, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE PT IS REPORTEDLY DOING WELL AND THE DEVICE REMAINS IMPLANTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAK DURING INITIAL IMPLANTATION AND IT WAS REPAIRED. THE CSF LEAK TOOK PLACE AFTER THE COCHLEOSTOMY. THE LEAK WAS REPAIRED WITH SOFT TISSUE AND FASCIA WAX OF THE COCHLEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343857 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1500-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Required Intervention