BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1061668 · Received June 17, 2008

    Report

    Report Number
    6000034-2008-00337
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 10, 2008
    Report Date
    June 17, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT HAD DEVELOPED A SKIN FLAP INFECTION. REPEATED TREATMENTS DID NOT SOLVE THE PROBLEM. THE DECISION WAS MADE TO EXPLANT THE PT'S DEVICE. THE EXPLANT DATE HAD NOT SCHEDULED AT THE TIME OF THIS REPORT. NO REIMPLANTATION PLANS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24R(ST) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention