BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1832495 · Received September 13, 2010

    Report

    Report Number
    6000034-2010-00603
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    July 21, 2010
    Report Date
    March 28, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED (B)(4) 2012.

    Description of Event or Problem · 1

    PER THE CLINIC, IMPLANT SURGERY ON (B)(6) 2010 COULD NOT BE COMPLETED DUE TO A MEDICAL/SURGICAL COMPLICATION. AN ADDITIONAL SURGERY WAS REQUIRED ON (B)(6) 2010 TO SUCCESSFULLY IMPLANT THE PATIENT.

    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 Required Intervention