BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1061667 · Received June 17, 2008

    Report

    Report Number
    6000034-2008-00338
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 26, 2008
    Report Date
    June 17, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, IN 2008, THE PT'S PARENTS REPORTED THE RECEIVER/STIMULATOR SITE WAS SWOLLEN. REPORTEDLY, THE SURGEON SUSPECTED AN ALLERGIC RESPONSE. THE PT WAS TREATED WITH PREDNISONE. THE SWELLING "SEEMED BETTER". THREE MONTHS LATER, THE INTERNAL MAGNET EXTRUDED THROUGH THE SKIN FLAP. THE SURGEON REPORTEDLY WAS CONCERNED ABOUT AN INFECTION STARTING DUE TO THE EXPOSED MAGNET. THE DECISION WAS MADE TO EXPLANT THE DEVICE. THE PT'S DEVICE WAS EXPLANTED THE FOLLOWING MONTH, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24R(CS) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention