BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 5

    MDR report key: 3315663 · Received August 11, 2013

    Report

    Report Number
    3315663
    Event Type
    Malfunction
    Date Received
    August 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    COCHLEAR AMERICAS, INC.
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THERE HAS BEEN A RECALL ON THIS DEVICE AND EVENTUALLY HER DEVICE FAILED IN THE LAST FEW WEEKS AND IT WAS DECIDED TO PROCEED WITH EXPLANT AND REIMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385315 NUCLEUS 5 IMPLANT, COCHLEAR MCM COCHLEAR AMERICAS, INC. C1512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR