BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 2112722 · Received May 27, 2011

    Report

    Report Number
    3006556115-2011-00259
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    February 3, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY EXPLANTED DUE TO LOSS OF LOCK. THE PT WAS REIMPLANTED WITH ANOTHER COCHLEAR IMPLANT. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO.

    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 38 YR