BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1387601 · Received May 20, 2009

    Report

    Report Number
    6000034-2009-00337
    Event Type
    Injury
    Date Received
    May 20, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 1, 2009
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT REPORTED A DECREASE IN PERFORMANCE. THE RESULTS OF MULTIPLE INTEGRITY TESTS IN 2008 INDICATE THE DEVICE IS FUNCTIONING WITHIN NORMAL LIMITS. EXPLANT AND REIMPLANTATION IS PLANNED, BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT MAY 19, 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24R (CS) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention