BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARPONIT SYSTEM SMART GRID SYSTEM

    MDR report key: 8072173 · Received November 14, 2018

    Report

    Report Number
    3002838670-2018-00004
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    November 3, 2018
    Report Date
    November 12, 2018
    Manufacturer
    MRI INTERVENTIONS INC.
    Product Code
    ORR
    PMA / PMN Number
    K100836
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON DOES NOT FELL CLEARPOINT SYSTEM WAS CAUSE OIF THE EVENT. THE MANUFACTURER OF THE MRI TABLE IMRIS HAS BEEN NOTIFIED OF TABLE MOVEMENT DURING PROCEDURE.

    Description of Event or Problem · 1

    FOLLOWING A BILATERAL DBS CASE, SOFTWARE TEAM ANALYZED THE DATA IT WAS LEARNED THAT THE TARGETING SEQUENCES AND THE FINAL T1 VOLUME WERE NOT IN THE SAME MR SPACE, AND THERE HAD BEEN A POSTERIOR SHIFT REQUIRING A SECOND BILATERAL DBS CASE PERFORMED IN ANOTHER ROOM. ROOT CAUSE DETERMINED THAT THE IMRIS TABLE MOVED DURING THE FIRST OPERATION CAUSING THE TARGETING SEQUENCE TO CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907834 CLEARPONIT SYSTEM SMART GRID SYSTEM SMARTGRID SYSTEM ORR MRI INTERVENTIONS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1