BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 369985 · Received January 2, 2002

    Report

    Report Number
    2029203-2001-00121
    Event Type
    Malfunction
    Date Received
    January 2, 2002
    Date of Event
    July 1, 2000
    Report Date
    December 20, 2001
    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 WAS SEEN AT THE IMPLANT CENTER FOR DEVICE EVALUATION IN 2000 AFTER SYSTEM CEASED FUNCTIONING AFTER A REPORTED FALL DOWN A STAIRWAY. TESTING CONDUCTED CONFIRMED THAT DEVICE WAS NO LONGER FUNCTIONING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR