BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1013650 · Received March 14, 2008

    Report

    Report Number
    6000034-2008-00104
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    December 28, 2007
    Report Date
    March 12, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT'S DEVICE WAS EXPLANTED IN 2007 DUE TO INCORRECT PLACEMENT OF THE ELECTRODE ARRAY IN THE COCHLEA. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE 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. CI24RE(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention