BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 638509 · Received September 29, 2005

    Report

    Report Number
    6000034-2005-00282
    Event Type
    Malfunction
    Date Received
    September 29, 2005
    Date of Event
    May 12, 2005
    Report Date
    September 29, 2005
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    AFTER A YEAR OF COCHLEAR IMPLANT USE, THE PT REPORTEDLY WAS NOT RESPONDING TO SOUND AND WAS REPORTING PAIN WHEN USING THEIR DEVICE. DIAGNOSTIC TESTING WAS CONSISTENT WITH ELECTRODE MALFUNCTION. ELECTRODES WERE DEACTIVATED FROM THE PATIENTS PROGRAM. EXPLANTATION SURGERY WAS SCHEDULED TO TAKE PLACE ON 9/15/2005.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention