BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22

    MDR report key: 10533117 · Received September 14, 2020

    Report

    Report Number
    6000034-2020-02234
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    November 2, 2018
    Report Date
    November 2, 2018
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P840024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SN OF THE AFFECTED DEVICE HAS BEEN CORRECTED AND NOTED THAT THIS IS A DEVICE MALFUNCTION. THIS REPORT IS SUBMITTED ON OCTOBER 30, 2020.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON SEPTEMBER 15, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996154 NUCLEUS 22 NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI22M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention