BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE

    MDR report key: 8193203 · Received December 23, 2018

    Report

    Report Number
    6000034-2018-02537
    Event Type
    Injury
    Date Received
    December 23, 2018
    Report Date
    February 14, 2025
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    UDI-DI
    09321502025683
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED), AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE IN (B)(6) 2019 (SPECIFIC DATE NOT REPORTED).

    Additional Manufacturer Narrative · 0

    CORRECTION: THE INITIAL MDR SUBMITTED ON DECEMBER 24, 2018, REPORTING ON INTEGRITY TEST WAS A DUPLICATE. THE INTEGRITY TEST WILL BE RECORDED UNDER COMPLAINT SYSTEM NUMBER, TW (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DATE OF AWARENESS HAS BEEN CONFIRMED AS (B)(6) 2018 AND NOT (B)(6) 2018 AS ORIGINALLY REPORTED IN THE EMDR SUBMITTED ON (B)(6) 2018. THIS REPORT IS FILED ON JANUARY 17, 2019.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED DECEMBER 24, 2018.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT SUSTAINED A HEAD TRAUMA AND SUBSEQUENTLY EXPERIENCED A PERFORMANCE DECREMENT. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND WAS ADMINISTERED ANTIBIOTICS (DATE AND TYPE NOT REPORTED). THE PATIENT IS BEING CLINICALLY MANAGED BY THE HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032281 NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CI24RE (ST) NA 09321502025683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention