BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 375778 · Received February 6, 2002

    Report

    Report Number
    2029203-2002-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2002
    Date of Event
    January 4, 2002
    Report Date
    February 5, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IN 2002, PATIENT WAS SEEN AT IMPLANT CENTER. TESTING CONDUCTED CONFIRMED THAT THE DEVICE WAS NOT FUNCTIONING. REVISION SURGERY WAS SCHEDULED. PATIENT 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-5100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR