BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1365505 · Received April 21, 2009

    Report

    Report Number
    6000034-2009-00238
    Event Type
    Malfunction
    Date Received
    April 21, 2009
    Date of Event
    March 31, 2009
    Report Date
    March 31, 2009
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER THE CENTER, THE PATIENT REPORTEDLY COULD NOT HEAR WITH THE DEVICE. AN INTEGRITY TEST WAS ATTEMPTED, BUT WAS NOT ABLE TO CONNECT TO THE IMPLANT. EXPLANT AND REIMPLANTATION IS PLANNED BUT HAD NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT, APRIL 21, 2009

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention