BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION IMPLANT

    MDR report key: 3812822 · Received May 6, 2014

    Report

    Report Number
    3006556115-2014-00203
    Event Type
    Injury
    Date Received
    May 6, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES. PROGRAMMING CHANGES WERE MADE, AND EXTERNAL EQUIPMENT WAS EXCHANGED. TROUBLESHOOTING REVEALED THAT THE DEVICE IS FUNCTIONING. THE ISSUE WAS NOT RESOLVED. DEVICE RECISION SURGERY HAS BEEN SCHEDULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271435 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention