BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1905162 · Received November 22, 2010

    Report

    Report Number
    6000034-2010-00723
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 18, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER PATIENT'S CLINIC, THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE ON (B)(6), 2010. THIS REPORT IS FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION (TYPE NOT REPORTED) RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED (B)(6), 2010. IT IS UNKNOWN WHETHER REIMPLANTATION IS PLANNED AT THE TIME OF THIS REPORT.

    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. CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention