BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TRIA

    MDR report key: 6600197 · Received May 31, 2017

    Report

    Report Number
    1723170-2017-02245
    Event Type
    Injury
    Date Received
    May 31, 2017
    Date of Event
    March 27, 2015
    Report Date
    August 2, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS APPROXIMATED. DATE PROVIDED IS WHEN THE JOURNAL ARTICLE WAS PUBLISHED ONLINE. CITATION: IIJIMA, K., HIRATO, M., MIYAGISHIMA, T., HORIGUCHI, K., SUGAWARA, K., ET AL. MICRO RECORDING AND IMAGE-GUIDED STEREOTACTIC BIOPSY OF DEEP-SEATED BRAIN TUMORS. J NEUROSURG (2015)123:978¿988. DOI: 10.3171/2014.10. (B)(4). PER THE JOURNAL ARTICLE, IMAGE-GUIDED STEREOTACTIC BIOPSY PERFORMED USING DEPTH MICRO RECORDING WAS SAFE, PROVIDED ACCURATE POSITIONAL INFORMATION IN REAL TIME, AND COULD DISTINGUISH THE BRAIN TUMOR FROM NORMAL BRAIN STRUCTURES DURING SURGERY. BASED ON CLINICAL JUDGEMENT AND EXPERIENCE, SENSORY DISTURBANCE IS A KNOWN INHERENT RISK OF THE PROCEDURE. NO FURTHER INFORMATION PROVIDED IN THE JOURNAL ARTICLE OR FROM THE AUTHORS. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER FOR EVALUATION. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION AND JOURNAL ARTICLE REVIEW WAS CONDUCTED. IT WAS CONFIRMED THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A SYSTEM CHECKOUT HAVE BEEN COMPLETED ON THIS SYSTEM SINCE THE EVENT DATE PER SYSTEM HISTORY AND CONFIRMED THE SYSTEM PERFORMED AS INTENDED.

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT PART NUMBER, SERIAL NUMBER, CATALOG NUMBER AND DEVICE MANUFACTURING DATE NOW PROVIDED.

    Description of Event or Problem · 1

    THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY A MEDTRONIC REPRESENTATIVE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS USED WITH MICRO RECORDING DURING TUMOR BIOPSY. THE PRESENT STUDY ASSESSED THE ACCURACY AND SAFETY OF THIS METHOD AND INVESTIGATED THE CORRELATIONS BETWEEN THE ELECTROPHYSIOLOGICAL, MRI, AND HISTOLOGICAL FINDINGS. DEFINITIVE HISTOLOGICAL DIAGNOSES WERE OBTAINED IN ALL 12 PATIENTS WHO UNDERWENT SURGERY WITH MICRO RECORDING, WITH A DIAGNOSTIC YIELD PER PATIENT OF 100%. TRANSIENT SENSORY DISTURBANCE WAS OBSERVED IN 1 PATIENT WITH MIDBRAIN TUMOR (CASE 11) JUST AFTER SURGERY WITH MICRO RECORDING (POST-OP). NO OTHER POSTOPERATIVE COMPLICATIONS OCCURRED. NO PERMANENT COMPLICATION, SYMPTOMATIC CEREBRAL HEMORRHAGE, OR POSTOPERATIVE DEATH WAS OBSERVED. STABLE THALAMIC NEURAL ACTIVITY WAS OBSERVED ALONG THE TRAJECTORY. INJURY DISCHARGES, WHICH WERE FOUND ONLY DURING INSERTION OF THE ELECTRODE, WERE ENCOUNTERED AT 0.5 TO 1 MM ALONG THE TRAJECTORY BETWEEN THE AREA OF DECREASED AND DISAPPEARED NEURAL ACTIVITY IN 9 PATIENTS. THE T2-WEIGHTED AND DIFFUSION WEIGHTED MRI STUDIES HAD SHOWN HIGH-INTENSITY LESION SURROUNDING THE ENHANCED LESION IN CASE 11, SO BIOPSY WAS PERFORMED WITHIN THE REGION OF THE T2-WEIGHTED MRI HIGH-INTENSITY LESION (DECREASED AND BURST NEURAL ACTIVITY) AS WELL AS WITHIN THE REGION OF ENHANCING LESION (DISAPPEARED NEURAL ACTIVITY) BECAUSE BOTH SAMPLES WERE NECESSARY FOR DIAGNOSIS. TISSUE SAMPLES WERE OBTAINED FROM REGIONS OF BURST AND DECREASED NEURAL ACTIVITY IN CASE 11 WITH MALIGNANT LYMPHOMA. IN THIS CASE, INVASION OF TUMOR CELLS AT A MUCH LOWER DENSITY WAS OBSERVED IN THE TISSUE SAMPLE TAKEN FROM THE REGION OF BURST AND DECREASED NEURAL ACTIVITY; THEREFORE, THE PROCEDURE CLEARLY AFFECTED THE FUNCTION OF NORMAL BRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383146 STEALTHSTATION TRIA NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) TRIA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other