BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2181185 · Received July 19, 2011

    Report

    Report Number
    3006556115-2011-00355
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    February 17, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT BECAME A NON-USER OF HIS DEVICE. THE PT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE, MORE INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention