BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2991918 · Received March 6, 2013

    Report

    Report Number
    6000034-2013-00449
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    July 23, 2012
    Report Date
    June 11, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE TIP OF THE ELECTRODE ARRAY WAS FOUND TO BE FOLDED OVER IN THE COCHLEA, RESULTING IN THE DECISION TO EXPLANT THE DEVICE.THE DEVICE WAS EXPLANTED ON (B)(6) 2012, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96206 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention