BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3831694 · Received May 27, 2014

    Report

    Report Number
    6000034-2014-00753
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 2, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED ON (B)(6) 2014. THIS REPORT IS FILED JUNE 6, 2014.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE (SPECIFIC DATE NOT REPORTED), HOWEVER THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311315 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 32 MO Required Intervention