BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 378993 · Received February 25, 2002

    Report

    Report Number
    2029203-2002-00009
    Event Type
    Malfunction
    Date Received
    February 25, 2002
    Date of Event
    January 1, 2002
    Report Date
    February 25, 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

    IN 2002, THE PT WAS SEEN AT THE IMPLANT CENTER FOR DEVICE EVAL. TESTING CONDUCTED AT THE CENTER DEMONSTRATED THAT THE SYSTEM WAS NOT FUNCTIONING. 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-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR