BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3003925 · Received December 8, 2008

    Report

    Report Number
    6000034-2008-00700
    Event Type
    Injury
    Date Received
    December 8, 2008
    Date of Event
    December 12, 2008
    Report Date
    November 11, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    890027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT HAS BEEN RESISTANT TO USING THE DEVICE FOR APPROXIMATELY THE LAST YEAR. THE PATIENT REMOVES THE SOUND PROCESSOR WHEN IT IS ACTIVATED. SHE WILL WEAR THE SOUND PROCESSOR IF IT IS TURNED OFF. REPORTEDLY, THE PATIENT HAS "MULTIPLE DISORDERS (INCLUDING SEVERE CP) AND IS NON-VERBAL". RESULTS OF AN INTEGRITY TEST DONE ON (B)(6) 2008 SHOWED NORMAL RECEIVER/STIMULATOR AND ELECTRODE ARRAY FUNCTION. THE PATIENT HAS AN IMPLANT IN THE CONTRALATERAL EAR. EXPLANT/REIMPLANT SURGERY IS SCHEDULED FOR (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention