BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22

    MDR report key: 8958860 · Received September 4, 2019

    Report

    Report Number
    6000034-2019-01716
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    June 5, 2019
    Report Date
    October 8, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED NOVEMBER 1, 2019. - ATTACHMENT: [153247 DEVICE ANALYSIS REPORT REG.PDF].

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON SEPT 4, 2019.

    Description of Event or Problem · 1

    PER THE SURGEON, THE DEVICE WAS EXPLANTED FOR AN UNKNOWN REASON. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752828 NUCLEUS 22 NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI22M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention