BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3129866 · Received May 24, 2013

    Report

    Report Number
    6000034-2013-00973
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 9, 2013
    Report Date
    October 1, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT PMA # IS P970051; NOT 970051 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED NOVEMBER 24, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT WAS PRESCRIBED AN ORAL ANTIBIOTIC (DOSAGE AND DATE NOT REPORTED). (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION WHICH RESULTED IN EXPLANTATION ON (B)(6)2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6) 2013. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230691 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI422 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention