BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1083716 · Received July 28, 2008

    Report

    Report Number
    3006556115-2008-00391
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS REPORTEDLY EXPERIENCING A DECREASE IN SOUND PERFORMANCE WITH HIS INTERNAL DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED; HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. SURGERY TO EXPLANT THE PATIENT'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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1