BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2905865 · Received January 10, 2013

    Report

    Report Number
    6000034-2013-00069
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 14, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT RETURNED TO MANUFACTURER DATE IS (B)(4) 2013; NOT (B)(4) 2012 AS PREVIOUSLY REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, DEVICE WAS EXPLANTED ON (B)(6) 2012, DUE TO MIGRATION OF THE ELECTRODE ARRAY. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13605 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24M

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention