BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1219511 · Received November 3, 2008

    Report

    Report Number
    6000034-2008-00620
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 10, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT FILED, NOVEMBER 03, 2008.

    Description of Event or Problem · 1

    PER THE SURGEON, THE PT DEVELOPED AN SKIN ULCERATION DIRECTLY OVER THE RECEIVER/STIMULATOR AREA TWO YEARS AFTER IMPLANT SURGERY. THE SITE BEGAN DRAINING. MRSA WAS CULTURED AND THE PT WAS TREATED WITH "ANTIMICROBIAL COVERAGE". THE PT'S DEVICE WAS EXPLANTED IN 2008. REIMPLANTATION SURGERY IS NOT PLANNED UNTIL THE WOUND SITE HAS HEALED. REPORTEDLY, THE PT HAS RESIDUAL HEARING IN THE CONTRALATERAL EAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention