BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2870150 · Received December 12, 2012

    Report

    Report Number
    6000034-2012-02321
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 19, 2012
    Report Date
    October 16, 2024
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT SERIAL NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE PATIENT, ON (B)(6) 2012, THE PATIENT EXPERIENCED STATIC AND PAIN WITH DEVICE USE. THE EQUIPMENT WAS REMOVED FROM SERVICE, AND THE ISSUE WAS RESOLVED BY EXCHANGING EQUIPMENT. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CP800

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention