BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2830706 · Received November 13, 2012

    Report

    Report Number
    6000034-2012-02178
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    November 6, 2012
    Report Date
    April 2, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED MIGRATION OF THE RECEIVER/STIMULATOR SUBSEQUENT TO PLACEMENT OF A "TIGHT-FITTING HELMET" ON THE PATIENT'S HEAD, APPROXIMATELY ON WEEK AFTER IMPLANTATION. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012, DURING WHICH THE DEVICE WAS EXPLANTED AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE.

    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. CI422

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Required Intervention