BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 2002135 · Received February 2, 2011

    Report

    Report Number
    3006556115-2011-00028
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED INTERMITTENCY BETWEEN THE EXTERNAL EQUIPMENT AND THE COCHLEAR IMPLANT. EXTERNAL EQUIPMENT WAS EXCHANGED. HOWEVER, THE REPORTED PROBLEM WAS NOT RESOLVED. FURTHER TESTING COULD NOT BE COMPLETED DUE TO LOSS OF LOCK. THE CENTER IS CONSULTING THE SURGEON ON A FURTHER ACTION PLAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR