BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION IMPLANT

    MDR report key: 3032196 · Received March 29, 2013

    Report

    Report Number
    3006556115-2013-00122
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT UNDERWENT URGENT MRI PROCEDURE WITH THE INTERNAL MAGNET IN PLACE. A COMPRESSION BANDAGE WAS USED DURING THE PROCEDURE SINCE THE MAGNET IN THE DEVICE WAS NOT REMOVABLE. THE PT HAS A BRAIN TUMOR NEAR THE INTERNAL DEVICE. THE PT WAS LATER EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130159 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100H-12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention