BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1092023 · Received July 31, 2008

    Report

    Report Number
    6000034-2008-00422
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 1, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    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. THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT HAD RECURRENT SKIN FLAP PROBLEMS (INFLAMMATION AND INFECTION). THE STIMULATOR REPORTEDLY WAS VISIBLE THROUGH AN OPEN SORE. THE PT'S DEVICE WAS EXPLANTED IN 2008. REIMPLANTATION IS PLANNED BUT HAD NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention