BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1930721 · Received December 16, 2010

    Report

    Report Number
    6000034-2010-00790
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 23, 2010
    Report Date
    February 24, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(4), 2012.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT STARTED USING HIS DEVICE AFTER SEVERAL YEARS OF INCONSISTENT USE. HE EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6), 2010 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY.

    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. CI24R (CS) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention