BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 493638 · Received October 31, 2003

    Report

    Report Number
    6000034-2003-00227
    Event Type
    Malfunction
    Date Received
    October 31, 2003
    Date of Event
    October 3, 2003
    Report Date
    October 31, 2003
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT FELL AND HIT HEAD. NO PROBLEMS OBSERVED UNTIL ONE WEEK AFTER THIS EVENT. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MANUFACTURER'S SPECIFICATIONS. EXPLANTATION/REIMPLANTATION SURGERY IS YET TO BE SCHEDULED. 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
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM 24 CHANNEL COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24RCS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention