BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 2003158 · Received February 14, 2011

    Report

    Report Number
    3006556115-2011-00058
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED PAIN AT THE IMPLANT SITE. THE PT ALSO EXPERIENCED INTERMITTENCIES FOLLOWED BY LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. SURGERY TO EXPLANT THE PT'S DEVICE WILL BE SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR