BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE

    MDR report key: 8630355 · Received May 21, 2019

    Report

    Report Number
    6000034-2019-00839
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    April 5, 2019
    Report Date
    May 3, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MAY 22, 2019. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2019 DUE TO AN INFECTION. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, MAY 22, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423221 NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (ST) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other| R