BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1213516 · Received October 27, 2008

    Report

    Report Number
    6000034-2008-00602
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 30, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FILED, OCTOBER 27, 2008.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, IN 2008, THE PATIENT REPORTED A SCAB OVER THE RECEIVER/STIMULATOR SITE. THE PATIENT'S DAUGHTER REPORTED THAT THE SCAB HAD BEEN THERE FOR SEVERAL MONTHS. REPORTEDLY, THE SURGEON TREATED THE SCAB BUT THEN NOTED THAT THE RECEIVER/STIMULATOR "SEEMED TO BE EXTRUDING". TO DETERMINE IF A SKIN GRAFT OR EXPLANT SURGERY WILL BE DONE, FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention