BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2220999 · Received August 23, 2011

    Report

    Report Number
    6000034-2011-00625
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    October 27, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(4) 2012.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO AN INFECTION THAT COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6), 2011. THERE ARE NO PLANS TO REIMPLANT THE PATIENT IN THIS EAR. THE PATIENT IS BILATERALLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention