BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 381931 · Received March 11, 2002

    Report

    Report Number
    2029203-2002-00051
    Event Type
    Malfunction
    Date Received
    March 11, 2002
    Date of Event
    February 11, 2002
    Report Date
    March 11, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SEEN BY COMPANY REPRESENTATIVE IN MAY 2000 FOR REPORT OF INTERMITTENT LINK. AT THAT TIME, EXCHANGE OF EXTERNAL EQUIPMENT WAS MADE AND REPORTED PROBLEM WAS RESOLVED. IN FEBRUARY 2002, THE PATIENT WAS SEEN AT THE IMPLANT CENTER FOR DEVICE LOCK PROBLEM. THE DECISION WAS MADE TO SCHEDULE REVISION SURGERY. PATIENT WILL BE 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-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR