BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 6049677 · Received October 23, 2016

    Report

    Report Number
    6000034-2016-02069
    Event Type
    Injury
    Date Received
    October 23, 2016
    Report Date
    December 16, 2016
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    UDI-DI
    09321502020268
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON OCTOBER 24, 2016, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). REGISTRATION NUMBER 3009092818. EXEMPTION NUMBER E2016011. H3 OTHER TEXT: IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2016, RE-IMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AS OF THE DATE OF THIS REPORT. THIS REPORT IS FILED ON DECEMBER 02, 2016, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). REGISTRATION NUMBER 3009092818. EXEMPTION NUMBER E2016011.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. EXPLANTATION IS PLANNED; HOWEVER IT IS UNKNOWN IF THIS HAS YET TO OCCUR AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700768 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI422 N/A 09321502020268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention