BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 380264 · Received March 5, 2002

    Report

    Report Number
    2029203-2002-00043
    Event Type
    Malfunction
    Date Received
    March 5, 2002
    Date of Event
    January 31, 2002
    Report Date
    March 1, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IN 10/2001, THE IMPLANT CENTER MEASURED OUT OF RANGE IMPEDANCE VALUES ON 3 ELECTRODES. THE PT WAS REPORTEDLY PERFORMING WELL WITH THE DEVICE AND CONTINUED TO BE MONITORED BY CENTER. IN 12/2001 A CO REP VISITED THE IMPLANT CENTER TO ASSIST WITH PT'S DEVICE EVAL. AT THAT TIME, RESULTS OF TESTING INDICATED ADD'L ELECTRODES THAT WERE OUT OF RANGE. THE PT CONTINUED TO PERFORM WELL WITH THE DEVICE AND WAS MONITORED BY THE CENTER. THE REVISION SURGERY WAS SCHEDULE IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION AB-5100H-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO