BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM

    MDR report key: 3090612 · Received May 2, 2013

    Report

    Report Number
    6000034-2013-00786
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    February 1, 2013
    Report Date
    August 6, 2013
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    00015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT BRAND NAME IS 'NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM'; NOT 'NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM' AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT PMA # IS 000015; NOT 970051 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED OCTOBER 1, 2013. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE SURGEON, THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2013, AND RELEASED ON (B)(6) 2013. DURING THE HOSPITALIZATION, A COURSE OF INTRAVENOUS NAFCILLIN (DOSAGE NOT REPORTED) WAS ADMINISTERED TO THE PATIENT. THE PATIENT CONTINUED THE COURSE OF INTRAVENOUS NAFCILLIN AFTER RELEASE FROM THE HOSPITAL. PER THE CLINIC, THERE ARE NO PLANS TO EXPLANT THE DEVICE AND REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(4). THE PATIENT HAS PERMANENTLY DISCONTINUED USE OF THE DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS READMITTED TO THE HOSPITAL IN (B)(6), 2013, (DATE NOT REPORTED) DUE TO POST-OPERATIVE SWELLING.THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192833 NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . ABI 24M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R