BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2820074 · Received November 6, 2012

    Report

    Report Number
    6000034-2012-02122
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED IMPROPER PLACEMENT OF THE BODY OF THE IMPLANTED DEVICE DURING INITIAL SURGERY ON (B)(6), 2011.THE DEVICE WAS PLACED BACK INTO CORRECT POSITION DURING A REVISION SURGERY (DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 33 MO Required Intervention