BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3211715 · Received July 8, 2013

    Report

    Report Number
    6000034-2013-01201
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 17, 2013
    Report Date
    October 4, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON (B)(6) 2013. THIS REPORT IS FILED DECEMBER 12, 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE; THE PATIENT WAS PRESCRIBED 875MG OF AUGMENTIN ON (B)(6) 2013 AND 975MG OF AMOX-CLAV ON (B)(6) 2013 TO TREAT INFECTION; INFECTION DID NOT RESOLVE. THE DEVICE WAS EXPLANTED (B)(6) 2013; REIMPLANTATION IS PLANNED BUT HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308564 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention