BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1912050 · Received December 1, 2010

    Report

    Report Number
    6000034-2010-00748
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 25, 2010
    Report Date
    September 30, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2011; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AND WAS TREATED FOR, SWELLING AROUND THE IMPLANT SITE ON THREE SEPARATE OCCASIONS ((B)(6) 2010, DATES NOT REPORTED.) THE PATIENT UNDERWENT A PROCEDURE TO DRAIN THE FLUID IN (B)(6) 2010 (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention