BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1083070 · Received March 12, 2008

    Report

    Report Number
    3006556115-2008-00127
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED A LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED. HOWEVER, THE PROBLEM WAS NOT RESOLVED. TESTING PERFORMED BY ADVANCED BIONICS REP SHOWED THAT THE DEVICE WAS NOT FUNCTIONING. SURGERY TO EXPLANT THE PATIENT'S DEVICE IS SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1