BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5965478 · Received September 20, 2016

    Report

    Report Number
    6000034-2016-01808
    Event Type
    Injury
    Date Received
    September 20, 2016
    Report Date
    October 10, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON SEPTEMBER 21, 2016, BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818. EXEMPTION NUMBER E2016011. H3 OTHER TEXT : IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON OCTOBER 24, 2016 BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. CORRECTION: THIS MDR WAS A DUPLICATE. THE INFECTION REPORTED IN THE INITIAL MDR SUBMITTED ON SEPTEMBER 21, 2016 WAS PREVIOUSLY REPORTED ON REPORT NUMBER 6000034-2014-01144.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO OCCURRENCES OF STAPHYLOCOCCUS AUREUS (DATE, DURATION AND TREATMENTS NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, WAS NOT MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614307 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RE (CA) N/A 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention