BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1083071 · Received March 12, 2008

    Report

    Report Number
    3006556115-2008-00121
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTS EXPERIENCING INTERMITTENT LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THE PROBLEM WAS NOT RESOLVED. TESTING PERFORMED BY THE CENTER CONFIRMED THAT THE DEVICE WAS NOT FUNCTIONING. A REVISION SURGERY WILL BE SCHEDULED FOR THIS PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1