BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3040050 · Received April 3, 2013

    Report

    Report Number
    3006556115-2013-00125
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED A DECREASE IN PERFORMANCE. PROGRAMMING CHANGES WERE MADE WITHOUT RESOLVE. THE PATIENT IS BEING TREATED WITH ANTIBIOTICS (TYPE UNKNOWN) FOR FLUID IN THE EAR AND MIDDLE EAR INFECTION. THE CENTER WILL PURSUE DEVICE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135751 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention