BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 4222296 · Received November 3, 2014

    Report

    Report Number
    6000034-2014-01602
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    May 21, 2014
    Report Date
    December 1, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SPEECH THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED JANUARY, 19TH, 2015.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT YET RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED LOSS OF SOUND SUBSEQUENT TO INADVERTENTLY PULLING OUT THE ELECTRODE ARRAY WHILE ATTEMPTING TO CLEAN THE EXTERNAL EAR CANAL BY ENT CLINIC. THE DEVICE WAS EXPLANTED ON (B)(6) 2014, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702610 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24M

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention