BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 3800581 · Received February 11, 2014

    Report

    Report Number
    3006556115-2014-00039
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    December 10, 2013
    Report Date
    January 21, 2014
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S DEVICE WAS EXPLANTED AND THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. ONCE ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90059 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR