BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2912666 · Received January 14, 2013

    Report

    Report Number
    6000034-2013-00052
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 11, 2012
    Report Date
    April 11, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS TAKEN ON THE HOSPITAL FOR WOUND TREATMENT AFTER SUSTAINING TRAUMA TO THE COCHLEAR IMPLANT SIDE OF THE HEAD. THE CASING OF THE EXTERNAL EQUIPMENT REPORTEDLY CRACKED CAUSING A LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20063 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CP800

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Congenital Anomaly| H| R