BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 002-1100 15W THERMAL THERAPY

    MDR report key: 7015202 · Received November 9, 2017

    Report

    Report Number
    1723170-2017-04567
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    December 29, 2016
    Report Date
    February 1, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    UDI-DI
    00643169584440
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER UPDATED TO PROPER VALUE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE AUTHOR. ACCORDING TO THE ARTICLE, 8 PATIENTS AVERAGE AGE OF 19.1 YEARS OLD. THEREFORE,(B)(6) USED FOR PATIENT AGE. EVENT DATE IS APPROXIMATED AS THIS ARTICLE WAS ACCEPTED ON (B)(6) 2016. CITATION: VICTOR X. DU, SHASHANK V. GANDHI, HAROLD L. REKATE, & ASHESH D. MEHTA. LASER INTERSTITIAL THERMAL THERAPY: A FIRST LINE TREATMENT FOR SEIZURES DUE TO HYPOTHALAMIC HAMARTOMA? (2017). EPILEPSIA, 58(SUPPL. 2):77¿84, 2017 DOI: 10.1111/EPI.13751. THE EXACT SYSTEM INFORMATION COULD NOT BE DETERMINED AS IT WAS NOT PROVIDED. HOWEVER, THE SYSTEM LISTED ON THIS FORM WAS AT THE ADDRESS LISTED IN THE ARTICLE DURING THE TIME SOME OF THE SURGERIES WERE COMPLETED AND SUSPECTED TO BE THE SYSTEM USED FOR THE PROCEDURES. MEDTRONIC DID NOT MANUFACTURE THE SYSTEM AT THE TIME STUDY BEGAN IN 2012 BUT INSTEAD LATER ACQUIRED THE SYSTEM IN 2015. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. 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'S MEDTRONIC THERMAL THERAPY SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY MEDTRONIC REPRESENTATIVE. USE OF THERMAL THERAPY SYSTEM WAS REPORTED. THE STUDY STARTED IN 2012 AND ENDED IN 2016. 8 PATIENTS WITH HYPOTHALAMIC HAMARTOMA (HH) UNDERWENT THE LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR HH TREATMENT. BASED ON THE ARTICLE, THE MEAN AGE IS 19.1 (TABLE 1). NO GENDER INFORMATION PROVIDED. A TOTAL OF NINE CATHETER/LASER FIBER ASSEMBLIES WERE PLACED IN THE EIGHT PATIENTS. DEPENDING ON THE TARGETED TISSUE AND SURROUNDING STRUCTURES, WHICH CAN DISSIPATE HEAT DEFERENTIALLY SUCH AS CEREBROSPINAL FLUID (CSF) AND BLOOD VESSELS, UP TO A 2¿4 CM CIRCUMFERENTIAL, SPHERICAL ABLATION CAN BE ACHIEVED. THE INTENSITY OF THE LASER ENERGY AS WELL AS THE DURATION OF TREATMENT IS MANUALLY CONTROLLED BY THE SURGEON DURING THIS PROCEDURE. ALTHOUGH IT IS POSSIBLE TO DELIVER UP TO 15 W, =8 WIS DELIVERED FOR >90 S TO ANY PART OF THE HH, AND NEAR THE PLANE OF ATTACHMENT, NO =5 W IS DELIVERED FOR NO =30 S. THIS IS DUE TO RISK OF INJURY TO THE CONTIGUOUS HYPOTHALAMUS, MAMMILLARY BODIES, AND MAMMILLOTHALAMIC TRACT. THE ARRHENIUS CALCULATION MAY BE USED TO ESTIMATE THE SIZE OF THE LESION AT 10 S INTERVALS. THIS CALCULATION DERIVES A TEMPERATURE AT A GIVEN SITE ON MAGNETIC RESONANCE IMAGING (MRI), WHICH MAY BE MANUALLY CHOSEN BY THE SURGEON. BY PLACING ONE SET OF SAFETY MARKERS AT THE TARGET AND ANOTHER SET AT VULNERABLE STRUCTURES, THE DELIVERY OF LITT MAY BE CONTROLLED BY SOFTWARE IN A CLOSED-LOOP FASHION TO MAINTAIN A 50¿90°C TEMPERATURE AT THE TARGET AND TO SHUT OFF WHEN TEMPERATURE RISES OVER 43°C AT ADJACENT TISSUE THAT IS INTENDED TO BE PROTECTED (FIG. 1, CENTER AND BOTTOM ROWS). AS ANOTHER SAFETY PRECAUTION, THE SURGEON MAY MANUALLY STOP THE TREATMENT AT ANY TIME IF THERE IS CONCERN. ALL PATIENTS WERE EXTUBATED ON THE SAME DAY AS THE PROCEDURE. PATIENTS WERE MONITORED IN AN INTENSIVE CARE UNIT (ICU) SETTING FOR 24 H, WITH URINE OUTPUT AND SERUM SODIUM MONITORED EVERY 6 H. NO PATIENT DEVELOPED DIABETES INSIPIDUS AS DEFINED BY HYPOTONIC POLYURIA. THE EIGHT PATIENTS STAYED IN THE HOSPITAL ON AVERAGE 2.6 DAYS TOTAL. SEIZURE AND BEHAVIORAL OUTCOMES WERE COLLECTED FOR EIGHT PATIENTS BASED ON CHART REVIEW AND TELEPHONE INTERVIEW, WITH AN AVERAGE POSTTREATMENT FOLLOW-UP PERIOD OF 19.1 MONTHS (RANGE 3¿30 MONTHS). POSTOPERATIVE OUTCOMES ARE LISTED IN TABLE 1. FOR ALL PATIENTS WITH EPILEPSY, IMPROVED SEIZURE CONTROL WAS OBSERVED, AND ALL ARE SEIZURE-FREE EXCEPT ONE PATIENT, WHO HAS 75% REDUCTION IN SEIZURE FREQUENCY. ALL FIVE PATIENTS WITH 1-YEAR FOLLOW-UP AND ALL FOUR WITH 2-YEAR FOLLOW-UP WERE SEIZURE-FREE. TWO OF THREE PATIENTS WITH BEHAVIORAL DISTURBANCE HAD RESOLUTION OF BEHAVIORAL SYMPTOMS. IN THIS STUDY, SIX OF SEVEN PATIENTS WHO UNDERWENT LITT TO TREAT EPILEPSY ARE SEIZURE-FREE AT AVERAGE 17.7 MONTHS OF FOLLOW-UP. THE ONE PATIENT WHO UNDERWENT LITT TO TREAT RAGE ATTACKS ONLY, DID NOT HAVE POSTTREATMENT IMPROVEMENT, WHEREAS BEHAVIORAL PROBLEMS DID IMPROVE IN TWO OF THE PATIENTS WITH EPILEPSY. NO PATIENT DEVELOPED DIABETES INSIPIDUS OR SENSORIMOTOR NEUROLOGIC DEFICIT FROM THE LITT PROCEDURE. ALTHOUGH WE DO NOT HAVE DETAILED NEUROPSYCHOLOGICAL FOLLOW-UP IN THE HIGHER FUNCTIONING PATIENTS, FOR THOSE WITH >6 MONTHS OF FOLLOW-UP, ALL PATIENTS OR PATIENT CARETAKERS SUBJECTIVELY NOTED IMPROVEMENT IN OVERALL FUNCTIONING. AS WITH ANY CRANIAL PROCEDURE, THERE IS A RISK OF POSTOPERATIVE HEMORRHAGE, AND THE PRESENT SERIES CALLS ATTENTION TO A TECHNICAL NUANCE OF THE PROCEDURE. THAT IS, SUCCESSFUL DURAL PUNCTURE MUST BE ENSURED AFTER TREPHINATION BEFORE ATTEMPTING TO PASS A DEVICE TO THE TARGET. OUR EXPERIENCE ALSO HIGHLIGHTS THE POTENTIAL OF SOFTWARE FAILURE IN THE CALCULATION OF THE ARRHENIUS EQUATION AND CAUTIONS AGAINST OVERRELIANCE ON THE CALCULATED HEAT MAPS AND SETTING OF SAFETY MARKERS. ONE PROCEDURE WAS COMPLICATED WITH AN EPIDURAL HEMATOMA. IT IS LIKELY THAT THIS OCCURRED AS A RESULT OF INADEQUATE DURAL PUNCTURE AND DISSECTION OF THE DURA FROM THE PERIOSTEUM DURING PLACEMENT OF THE ALIGNMENT ROD. THE EPIDURAL HEMATOMA WAS SEEN ON THE SCOUT MRI (PATIENT 5 IN FIG. 2, MIDDLE ROW), BUT THE MASS EFFECT WAS LOCAL AND THE SIZE OF THE HEMATOMA COULD BE MONITORED DURING THE 10-MIN TREATMENT, IT WAS POSSIBLE TO COMPLETE THE ABLATION. THE PATIENT WAS THEN RETURNED TO THE OPERATING ROOM PRIOR TO EXTUBATION WHERE A CRANIOTOMY WAS PERFORMED TO EVACUATE THE HEMATOMA. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE THIRD POSTOPERATIVE DAY WITHOUT NEUROLOGIC DEFICIT. IN ANOTHER PATIENT, THERE WAS A FAILURE OF THE SOFTWARE TO GENERATE ACCURATE DAMAGE ESTIMATES USING THE ARRHENIUS EQUATION THAT BECAME APPARENT ONLY AFTER TREATMENT HAD BEEN INITIATED. IN THIS CASE, THE DEVICE WAS STOPPED MANUALLY STOPPED BASED ON DOSIMETRY, SUCH THAT UP TO 30 S OF 5 W WAS DELIVERED TO THE POINT OF ATTACHMENT OF THE HAMARTOMA TO THE HYPOTHALAMUS. NONETHELESS, MRI IMAGING CONFIRMED THE LESION TO INCLUDE AND BE RESTRICTED TO THE TARGETED AREA. DUE TO THE PRESENCE OF A SMALL CONTRALATERAL REMNANT, ONE PATIENT UNDERWENT ADDITIONAL TREATMENT WITH GAMMA KNIFE 2 WEEKS AFTER THE LITT PROCEDURE. HOWEVER, GIVEN HER IMMEDIATE SEIZURE-FREE OUTCOME, IT IS LIKELY THAT THE LITT PROVIDED ADEQUATE TREATMENT TO HER MOST DISABLING SEIZURES. IN OUR SERIES, LITT HAS BEEN WELL TOLERATED, AND RESULTED IN MINIMAL SERIOUS COMPLICATIONS, SHORT HOSPITALIZATION, AND EXCELLENT SEIZURE CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792588 SYSTEM 002-1100 15W THERMAL THERAPY POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 00643169584440

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| O| R