BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 380252 · Received March 10, 2002

    Report

    Report Number
    2029203-2002-00020
    Event Type
    Malfunction
    Date Received
    March 10, 2002
    Date of Event
    January 29, 2002
    Report Date
    March 1, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT'S PARENT REPORTED TO THE CENTER THAT A FALL AND SUBSEQUENT SEIZURE HAD TAKEN PLACE APPROX A YEAR PRIOR TO CENTER VISIT IN 1/2002. BECAUSE OF PT'S HISTORY OF SEIZURES AND DUE TO EXTERNAL HEADPIECE BEING LOST, THE PT USED THE DEVICE MINIMALLY DURING THIS PAST YEAR. IN 1/2002, THE PT VISITED THE CENTER FOR DEVICE EVAL. AT THAT TIME THE TESTING CONDUCTED BY THE CENTER INDICATED THAT DEVICE WAS NOT FUNCTIONING. A CO REP VISITED THE CENTER AND CONFIRMED THAT THE 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-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR