BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2942634 · Received February 4, 2013

    Report

    Report Number
    6000034-2013-00178
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 21, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER PATIENT'S PARENT, THE PATIENT EXPERIENCED INFECTION AT THE IMPLANT SITE. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2013 TO HAVE SITE DRAINED. ON (B)(6) 2013, THE PATIENT WAS PRESCRIBED AMOXICILLIN (AMOUNT UNKNOWN) FOR TEN DAYS. AT PATIENT VISIT ON (B)(6) 2013, THE HEALTHCARE PROVIDER INDICATED THAT THE INFECTION HAD RESOLVED. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47083 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention