BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1021417 · Received March 24, 2008

    Report

    Report Number
    3006556115-2008-00140
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED SEVERAL EPISODES OF PAIN FOLLOWED BY A LOSS OF LOCK WITH THE DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THE PROBLEM WAS NOT RESOLVED. TESTING AT THE CENTER CONFIRMED THAT THE DEVICE WAS NOT FUNCTIONING. A REVISION SURGERY HAS BEEN SCHEDULED TO EXPLANT THE PT'S DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1