BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3081976 · Received April 29, 2013

    Report

    Report Number
    6000034-2013-00728
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    January 7, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON 28 FEB 2014.

    Additional Manufacturer Narrative · 1

    PER THE SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AROUND THE IMPLANT SITE, WITH AND WITHOUT DEVICE USE. THE ISSUE COULD NOT BE RESOLVED, LEADING TO DEVICE NON-USE (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.THERE ARE PLANS TO EXPLANT THE DEVICE; HOWEVER, IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, APRIL 28TH, 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185407 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention