BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3931879 · Received June 20, 2014

    Report

    Report Number
    3006556115-2014-00297
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S DEVICE WAS REPORTEDLY EXPLANTED DUE TO INFECTION. ADVANCED BIONICS IS CURRENTLY IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364071 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Required Intervention