BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 536219 · Received March 12, 2004

    Report

    Report Number
    2029203-2004-00048
    Event Type
    Malfunction
    Date Received
    March 12, 2004
    Date of Event
    February 18, 2004
    Report Date
    March 11, 2004
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED A CHANGE IN LOUDNESS PERCEPTION. THE PT WAS SEEN AT THE CENTER, PROGRAMMING CHANGES WERE MADE. IN 02/2004, THE PT'S EDUCATORS REPORTEDLY OBSERVED A DECREASE IN THE PT'S RESPONSES. IN 02/2004, THE PT WAS SEEN AT THE CENTER. PROGRAMMING CHANGES WERE MADE. IN 02/2004, THE PT WAS SEEN BY A COMPANY REP FOR DEVICE EVALUATION. THE PT WAS NOT WEARING THE SOUND PROCESSOR. TESTING PERFORMED CONFIRMED THAT THE DEVICE WAS FUNCTIONING. PROGRAMMING ADJUSTMENTS WERE MADE. THE PT CONTINUED TO BE MONITORED BY THE CENTER. IN 2004, THE PT'S SOUND PROCESSOR REPORTEDLY WAS NOT WORKING. THE PT WAS SEEN AT THE CENTER FOR DEVICE EVALUATION. EXTERNAL EQUIPMENT WAS EXCHANGED. TESTING PERFORMED CONFIRMED THAT THE DEVICE WAS NO LONGER FUNCTIONING. THE PT'S C1 DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANTHER ADVANCED BIONICS COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP. AB-5100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR