BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3803254 · Received May 9, 2014

    Report

    Report Number
    6000034-2014-00712
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS (DATE NOT REPORTED) DUE TO SWELLING AND REDNESS AT THE INCISION SITE. ON (B)(6) 2014 A PE TUBE WAS PLACED TO DRAIN THE SITE AND ORAL ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 FOR MASTOIDITIS AND ABSCESS; SUBSEQUENTLY UNDERGOING SURGERY (B)(6) 2014 TO CLEAN THE WOUND. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282012 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R