BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1030621 · Received April 16, 2008

    Report

    Report Number
    3006556115-2008-00187
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED A LOSS OF LOCK WITH HIS INTERNAL DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. THE PT'S DEVICE WAS EXPLANTED AND WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1