BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 4863903 · Received June 23, 2015

    Report

    Report Number
    6000034-2015-01061
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 1, 2015
    Report Date
    August 18, 2015
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT MODEL NUMBER IS CI24M; NOT CI24RE (CA) AS PREVIOUSLY REPORTED. THIS REPORT IS FILED NOVEMBER 4, 2015.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE ARRAY HAD MIGRATED EXTRA COCHLEA RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2015; DURING THE SAME SURGERY THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404984 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CI24M

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention