BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 534537 · Received March 11, 2004

    Report

    Report Number
    2029203-2004-00051
    Event Type
    Malfunction
    Date Received
    March 11, 2004
    Date of Event
    February 20, 2004
    Report Date
    March 11, 2004
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IN 02/2004, WHILE USING THE SOUND PROCESSOR, THE PT REPORTEDLY EXPERIENCED AN OVERLY LOUD SENSATION FOLLOWED BY NO SOUND. IN 02/2004, THE PT WAS SEEN AT THE CENTER FOR DEVICE EVALUATION. EXTERNAL EQUIPMENT WAS EXCHANGED. HOWEVER, THE PROBLEM WAS NOT RESOLVED. THE NEXT DAY, THE PT WAS SEEN AT THE CENTER. TESTING PERFORMED CONFIRMED THAT THE DEVICE WAS NO LONGER FUNCTIONING. SURGERY TO EXPLANT THE PT'S C1 DEVICE HAS BEEN SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR