BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COCHLEAR NUCLEUS CI512

    MDR report key: 5266837 · Received December 4, 2015

    Report

    Report Number
    5266837
    Event Type
    Malfunction
    Date Received
    December 4, 2015
    Date of Event
    September 26, 2014
    Report Date
    November 11, 2015
    Manufacturer
    COCHLEAR AMERICAS, INC.
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: COCHLEAR IMPLANT DEVICE FAILURE. POST-OP DIAGNOSIS: SAME. PROCEDURE(S): RIGHT EXPLANTATION AND RE-IMPLANTATION OF COCHLEAR IMPLANT. CA NUCLEUS FREEDOM CONTOUR ADVANCE ELECTRODE. FROM OFFICE VISIT APPROXIMATELY TWO WEEKS EARLIER: "...SHE RECEIVED A CI512 DEVICE IN THE RIGHT EAR APPROXIMATELY 5 YEARS AGO, AND DID WELL FOR SEVERAL YEARS. THIS PAST (B)(6), THE PATIENT BEGAN TO NOTICE THE DEVICE CUTTING OUT FREQUENTLY, BEFORE GOING OUT COMPLETELY FOR 5-6 WEEKS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798959 COCHLEAR NUCLEUS CI512 IMPLANT, COCHLEAR MCM COCHLEAR AMERICAS, INC. NUCLEUS 512 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR