BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 301439 · Received October 18, 2000

    Report

    Report Number
    2029203-2000-00035
    Event Type
    Other
    Date Received
    October 18, 2000
    Date of Event
    September 1, 2000
    Report Date
    October 10, 2000
    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 PT WAS SEEN AT THE IMPLANT CENTER FOR DEVICE EVAL IN 2000. TESTING CONDUCTED AT THE CENTER CONFIRMED THAT THE PT'S DEVICE WAS NO LONGER FUNCTIONING. REVISION SURGERY TOOK PLACE IN 2000. THE PT WAS REIMPLANTED WITH ANOTHER CLARION DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR