BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 500827 · Received December 4, 2003

    Report

    Report Number
    6000034-2003-00245
    Event Type
    Malfunction
    Date Received
    December 4, 2003
    Date of Event
    October 22, 2003
    Report Date
    December 4, 2003
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A BLOW TO THE HEAD WITH A SUBSEQUENT DISINTEGRATION OF SOUND QUALITY. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MANUFACTUER'S SPECIFICATIONS. EXPLANTATION/REIMPLANTATION SURGERY WAS PERFORMED IN 2003. 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 34 YR