BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 370013 · Received January 2, 2002

    Report

    Report Number
    2029203-2001-00096
    Event Type
    Malfunction
    Date Received
    January 2, 2002
    Date of Event
    December 1, 2001
    Report Date
    January 2, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY HAD BEEN DOING WELL WITH THE DEVICE. THE DEVICE SUDDENLY STOPPED FUNCTIONING AND THE EVALUATION BY THE CENTER CONFIRMED THAT THE UNIT WAS NO LONGER FUNCTIONING. PATIENT REQUESTED REIMPLANTATION WITH ANOTHER CLARION DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR