BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2862852 · Received December 10, 2012

    Report

    Report Number
    6000034-2012-02312
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    September 10, 2012
    Report Date
    February 1, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER THE SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013; IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AROUND THE INCISION SITE. ON (B)(6) 2012, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO CLEAN THE AFFECTED SITE. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED FOR 15 DAYS. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL THE FIRST WEEK OF OCTOBER (SPECIFIC DATE NOT REPORTED) AND AN ADDITIONAL SURGICAL PROCEDURE TO CLEAR THE SITE WAS PERFORMED. FOLLOW UP ON (B)(6) 2012 INDICATED THAT PATIENT HAS AN INFECTION. THERE ARE PLANS TO EXPLANT THE DEVICE, HOWEVER IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 MO Required Intervention