BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION IMPLANT

    MDR report key: 3213386 · Received July 3, 2013

    Report

    Report Number
    3006556115-2013-00294
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED INTERMITTENCIES. EXCHANGING THE EXTERNAL EQUIPMENT RESOLVED THIS ISSUE, HOWEVER, THE PT HAS ELECTED TO HAVE THE DEVICE EXPLANTED FOR A TECHNOLOGY UPGRADE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. ONCE MORE INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306346 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention