BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 3100616 · Received May 8, 2013

    Report

    Report Number
    6000034-2013-00840
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED A SKIN FLAP BREAKDOWN WITH INTERNAL DEVICE EXPOSURE IN (B)(6) 2013 (DATE NOT SPECIFIED) AND UNDERWENT SKIN FLAP DEBRIDEMENT ON (B)(6) 2013. THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200572 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM MCM COCHLEAR LTD CI24R (CS) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention