BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1021453 · Received March 24, 2008

    Report

    Report Number
    3006556115-2008-00143
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A SOUND QUALITY ISSUE FOLLOWED BY A LOSS OF LOCK WITH THE DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE CENTER DECIDED THAT THE DEVICE WAS NOT FUNCTIONING. SURGERY TO EXPLANT THE PT'S DEVICE AND RE-IMPLANT WITH ANOTHER DEVICE WILL BE SCHEDULED. ADVANCED BIONICS IS CURRENTLY IN THE PROCESS OF GATHERING ADD'L INFO. WHEN MORE INFO BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT.

    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