BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 9789749 · Received March 4, 2020

    Report

    Report Number
    6000034-2020-00595
    Event Type
    Injury
    Date Received
    March 4, 2020
    Date of Event
    January 6, 2020
    Report Date
    August 7, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED 2 SEPTEMBER 2020. ATTACHMENT: [162769-DEVICE ANALYSIS REPORT.PDF]

    Additional Manufacturer Narrative · 0

    IT HAS NOW BEEN REPORTED THAT THE INFECTION WAS TREATED WITH AN ANTIBIOTIC (TYPE OF ADMINISTRATION UNKNOWN). THIS REPORT IS SUBMITTED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 5, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE. THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. CLINICAL MANAGEMENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253132 NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) NA 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention