BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3093298 · Received May 6, 2013

    Report

    Report Number
    6000034-2013-00825
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 14, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013. CORRECTION: THE CORRECT SERIAL NUMBER IS (B)(4); NOT (B)(4) AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN FLAP INFECTION AROUND THE IMPLANT SIDE. TREATMENT WITH ANTIBIOTICS IN (B)(6) 2013 (SPECIFIC DATE AND TYPE NOT REPORTED) WAS UNSUCCESSFUL. THE DEVICE WAS EXPLANTED IN (B)(6) 2013 (SPECIFIC DATE NOT REPORTED). IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196663 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RST

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention