BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 363934 · Received November 30, 2001

    Report

    Report Number
    6000034-2001-00158
    Event Type
    Malfunction
    Date Received
    November 30, 2001
    Date of Event
    August 8, 2000
    Report Date
    November 30, 2001
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HIT HEAD PRIOR TO THE PT NOT BEING ABLE TO WEAR DEVICE. USING APPROPRIATE DIAGNOSTIC EQUIPMENT, MULTIPLE OPENS AND SHORTS WERE FOUND. EXPLANTATION/REIMPLANTATION SURGERY OCCURRED IN 2001. THE HEALTHCARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEVICE SHOULD BE RETURNED TO COCHLEAR LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53973 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM 24 CHANNEL COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR