BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 4173506 · Received October 10, 2014

    Report

    Report Number
    3006556115-2014-00527
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED A DECREASE IN PERFORMANCE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING CHANGE WAS MADE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. REVISION SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642648 CLARION IMPLANT CHCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR