BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 7405999 · Received April 8, 2018

    Report

    Report Number
    6000034-2018-00691
    Event Type
    Injury
    Date Received
    April 8, 2018
    Date of Event
    March 3, 2018
    Report Date
    March 16, 2018
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON APRIL 9, 2018, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011. - ATTACHMENT: [111072 DEVICE ANALYSIS REPORT.PDF]

    Description of Event or Problem · 0

    PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT TESTED (B)(6) FOR AN (B)(6) INFECTION. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018, IN ORDER TO DEBRIDE AN ABSCESS AT THE IMPLANT SITE AND REVISE THE MASTOIDECTOMY. DURING THE PROCEDURE, THE DEVICE WAS EXPLANTED. THE PATIENT WILL BE TREATED WITH ORAL AND ANTIBIOTICS FOR A DURATION OF 3 MONTHS FOLLOWING THE EXPLANT. THE PATIENT WAS NOT REIMPLANTED, AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248552 NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) NA 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention