BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COCHLEAR IMPLANT MODEL CI512 WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8710675 · Received June 19, 2019

    Report

    Report Number
    6000034-2019-01066
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 30, 2019
    Report Date
    October 29, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2019. THIS REPORT IS SUBMITTED SEPTEMBER 03, 2019.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED 25 NOVEMBER 2019. - ATTACHMENT: [151860 DEVICE ANALYSIS REPORT.PDF].

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JUNE 19, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, JUNE 19 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504323 COCHLEAR IMPLANT MODEL CI512 WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 NA 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other| R