BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEARPOINT

    MDR report key: 6873544 · Received September 18, 2017

    Report

    Report Number
    1125732-2017-00003
    Event Type
    Death
    Date Received
    September 18, 2017
    Date of Event
    April 14, 2017
    Report Date
    May 17, 2017
    Manufacturer
    MRI INTERVENTIONS, INC.
    Product Code
    ORR
    PMA / PMN Number
    K160434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON BELIEVES THE EVENT WAS DUE TO THE CLEARPOINT/VISUALASE PROCEDURE INITIATING THESE CASCADING EVENTS, BUT ON REVIEW OF THE CASE COULD NOT DETERMINE A SPECIFIC CAUSE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PTX HAD A PREVIOUS BIOPSY APPROXIMATELY 1 MONTH PRIOR TO THIS PROCEDURE CONFIRMING A GLIOMA. A CLEARPOINT/VISUALASE PROCEDURE WAS PERFORMED ON (B)(6). DURING THE PROCEDURE ALL INDICATIONS WERE NORMAL, WITH THE STYLET AND VISUALASE PROBE AT THE INTENDED TARGET. WITHIN 6-8 HOURS FOLLOWING COMPLETION THE PTX BEGAN TO DETERIORATE. EXAMINATION DETERMINED THE PTX HAD A SUBARACHNOID HEMORRHAGE. A DRAIN WAS PLACED TO RELIEVE PRESSURE. APPROXIMATELY 1-2 DAYS AFTER THE PTX EXPERIENCED A CEREBRUM STROKE AND SURGICAL DECOMPRESSION WAS PERFORMED, BUT THE PTX CONTINUED TO SUFFER PROGRESSING AND EVOLVING ISCHEMIA AND STROKE TO OTHER PARTS OF THE BRAIN. THE PATIENT DIED 4 DAYS AFTER THE PROCEDURE FROM PROGRESSING AND EVOLVING ISCHEMIA AND STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653492 CLEARPOINT NEUROLOGICAL STEREOTACTIC INSTRUMENT ORR MRI INTERVENTIONS, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death