BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1251716 · Received December 3, 2008

    Report

    Report Number
    6000034-2008-00686
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 20, 2008
    Report Date
    November 27, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE ELECTRODE ARRAY WAS NOT PLACED CORRECTLY IN THE PATIENT'S COCHLEA DURING THE INITIAL SURGERY. THE PATIENT'S DEVICE WAS EXPLANTED IN 2008, 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 MCM COCHLEAR LTD. CI24RE(CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention