BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEARPOINT SYSTEM

    MDR report key: 2909376 · Received January 8, 2013

    Report

    Report Number
    1125732-2013-00001
    Event Type
    Death
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 9, 2013
    Manufacturer
    MRI INTERVENTIONS, INC.
    Product Code
    ORR
    PMA / PMN Number
    K100836
    Removal / Correction Number
    NOT APPLICABLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TO OUR KNOWLEDGE, THERE HAS BEEN NO SUGGESTION OF FAILURE OR MALFUNCTION OF ANY COMPONENT OF THE CLEARPOINT SYSTEM MADE OR ALLEGED BY THE INSTITUTION OR OTHER HEALTH PROFESSIONAL.

    Description of Event or Problem · 1

    THE CLEARPOINT SYSTEM WAS USED BY SURGEONS AT (B)(6). THE PT DEVELOPED COMPLICATIONS FOLLOWING THE PROCEDURE AND PASSED AWAY DUE TO THESE COMPLICATIONS. THERE HAS BEEN NO ALLEGATION SUCH COMPLICATIONS WERE DUE FROM ANY MALFUNCTION OF THE CLEARPOINT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10029 CLEARPOINT SYSTEM NEUROLOGIC STEREOTAXIC, 21CFR 882.4560 ORR MRI INTERVENTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death