BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5895518 · Received August 23, 2016

    Report

    Report Number
    6000034-2016-01678
    Event Type
    Injury
    Date Received
    August 23, 2016
    Date of Event
    August 10, 2016
    Report Date
    September 5, 2016
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, IT WAS REPORTED THAT THE INFECTION EXPERIENCED BY THE PATIENT WAS NOT DEVICE RELATED. THIS REPORT IS FILED SEPTEMBER 16, 2016.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON AUGUST 23, 2013. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2016 DUE TO AN INFECTION AT IMPLANT SITE. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548665 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention