BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISUALASE

    MDR report key: 8157791 · Received December 12, 2018

    Report

    Report Number
    1723170-2018-06192
    Event Type
    Death
    Date Received
    December 12, 2018
    Date of Event
    July 28, 2018
    Report Date
    December 11, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    UDI-DI
    00643169655935
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER NOT PROVIDED IN ARTICLE. PATIENT WEIGHT NOT PROVIDED IN ARTICLE. DATE OF DEATH WAS NOT PROVIDED. EVENT DATE WAS NOT PROVIDED. DATE PUBLICATION WAS ACCEPTED IS PROVIDED, SYSTEM SERIAL NUMBER USED FOR PROCEDURE WAS NOT PROVIDED IN ARTICLE. SERIAL NUMBER PROVIDED IS ONE OF SITE'S SYSTEMS. NO EVALUATION PERFORMED AS THIS EVENT WAS REPORTED THROUGH LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: ZERVOS TM, ROBIN AM, LEE I. BMJ CASE REP PUBLISHED ONLINE FIRST: [28 JULY 2018]. DOI:10.1136/BCR-2018-225473 SUMMARY: SINCE THERE IS NO CURE FOR GLIOBLASTOMA MULTIFORME (GBM), THE GOAL OF TREATMENT BECOMES PROLONGING THE SURVIVAL THROUGH CYTOREDUCTION WHILE MINIMISING NEUROLOGICAL DEFICITS. IN THIS CASE REPORT, LASER INTERSTITIAL THERMAL THERAPY (LITT) WAS USED ONCE THE TUMOUR PROGRESSED INTO THE ISTHMUS OF THE CINGULATE GYRUS. ONE YEAR AFTER TEMPORAL LOBECTOMY, DISORDERS OF MEMORY, EMOTION, PERSONALITY AND NAVIGATION, LIKELY RELATED TO LIMBIC SYSTEM INVOLVEMENT ALONG WITH HALLUCINATIONS AND FLUCTUATING COGNITION OCCURRED AS THE TUMOUR PROGRESSED. AFTER ABLATION OF THE POSTERIOR CINGULUM, WORSENING OF TOPOGRAPHICAL DISORIENTATION WAS OBSERVED. PER LITERATURE REVIEW, DELIRIUM HAS BEEN NOTED IN PATIENTS WITH STROKES INVOLVING THE RIGHT-SIDED TEMPORO-PARIETOOCCIPITAL JUNCTION, AND TOPOGRAPHICAL DISORIENTATION HAS BEEN ASSOCIATED WITH LESIONS OF THE RIGHT POSTERIOR CINGULUM. ALTERNATIVE CAUSES OF THESE DEFICITS WERE RULED OUT, LEAVING STRUCTURAL CHANGES AS THE PRIMARY EXPLANATION. THIS IS THE FIRST REPORT OF THE NEUROLOGICAL DEFICITS ASSOCIATED WITH TUMOUR PROGRESSION AND VASOGENIC OEDEMA IN THIS REGION. REPORTED EVENT: A (B)(6) MALE UNDERWENT ELECTED LITT OVER OPEN CRANIOTOMY. STEREOTACTIC BIOPSY WAS FOLLOWED BY LASER INTERSTITIAL THERMAL ABLATION USING MEDTRONIC'S THERMAL THERAPY SYSTEM. THE ABLATION WAS CONFIRMED THROUGH INTRA-OPERATIVE MRI AND THE PATIENT RECOVERED UNEVENTFULLY. ONE YEAR LATER, PROGRESSIVE DELUSIONS AND PARANOIA OCCURRED REQUIRING HOSPITALISATION. THE PATIENT EXPERIENCED FLUCTUATING RESTLESSNESS, CONFUSION AND VISUAL HALLUCINATION ALONG WITH PARANOID DELUSIONS. REPEAT MRI SHOWED PROGRESSION OF DISEASE INTO THE POSTERIOR BORDER OF THE PREVIOUS ABLATION ZONE OF EXTENDING TO THE ISTHMUS OF THE CINGULATE GYRUS. REPEAT LITT WAS PERFORMED USING A NON-MEDTRONIC PRODUCT. THE PATIENT WAS PLACED ON 16 MG/DAY OF DEXAMETHASONE IN ANTICIPATION OF POSTOPERATIVE OEDEMA. THE DELIRIUM WAS FIRST TREATED THROUGH AVOIDANCE OF BENZODIAZEPINES AND ANTICHOLINERGIC MEDICATIONS AND MAINTENANCE OF AN APPROPRIATE SLEEP¿WAKE CYCLE. NEXT, DEXAMETHASONE WAS TAPERED TO 1 MG TWICE DAILY AND LEVETIRACETAM WAS REPLACED WITH DIVALPROEX. WHILE THESE MEDICATIONS CAN CAUSE ALTERED MENTAL STATUS, HE WAS TREATED WITH THESE MEDICATION SINCE HIS ORIGINAL DIAGNOSIS 2 YEARS PRIOR WITHOUT SIGNIFICANT SIDE EFFECTS. EEG AND CSF LABORATORIES WERE UNREMARKABLE. HE WAS TREATED WITH RISPERIDONE AND DIVALPROEX AND WAS DISCHARGED HOME. OV ER THE FOLLOWING WEEK, THE DELIRIUM IMPROVED; HOWEVER, HE CONTINUED TO HAVE BEHAVIOURAL CHANGES AND TOPOGRAPHICAL DISORIENTATION. HE DEVELOPED AN INSATIABLE APPETITE AND WAS CONVINCED THAT HIS BLOOD GLUCOSE LEVELS WERE LOW ALONG WITH AGITATION. DESPITE NOT EXHIBITING FOCAL WEAKNESS ON NEUROLOGICAL EXAMINATION, HE HAD DIFFICULTY WITH SPATIAL TASKS SUCH AS MISJUDGING THE DISTANCE TO A CHAIR AND REPEATEDLY FALLING WHEN ATTEMPTING TO SIT. HE ALSO EXPERIENCED DIFFICULTY WITH THE ORIENTATION OF CLOTHING SUCH AS PUTTING A SHIRT ON BACKWARDS. ON EXAMINATION, HE WAS ORIENTED WITH INTACT RECALL, STRENGTH, COORDINATION, AND ON CRANIAL NERVE EXAMINATION, HOWEVER, HE WAS UNABLE TO DETERMINE DIFFERENTIATED SIDEDNESS OF HEARING. HE WAS EVENTUALLY REHOSPITALISED FOR WORSENING DELIRIUM AND TAKEN INTO THE CARE OF A HOSPICE TEAM. TWO MONTHS AFTER THE LAST TREATMENT WITH LITT, HE EXPIRED AT HOME. THIS WAS APPROXIMATELY ONE YEAR AFTER MEDTRONIC LITT AND TWO YEARS AFTER INITIAL DIAGNOSIS. THE ARTICLE REPORTED THAT AS THE TUMOUR PROGRESSED INTO THE ISTHMUS OF THE CINGULATE GYRUS, PROFOUND CHANGES IN AWARENESS OCCURRED AND IT WAS CONCEIVABLE THAT DAMAGE TO THIS REGION COULD EXPLAIN THE PSYCHOLOGICAL CHANGES. THE ARTICLE REPORTED THAT IN THIS CASE, PRECISE ABLATION OF ENHANCING TISSUE LOCATED IN THE POSTERIOR CINGULATE GYRUS WAS ACHIEVED; HOWEVER, DESPITE THIS, WORSENING OF TOPOGRAPHICAL DISORIENTATION WAS OBSERVED. THIS WAS COUPLED WITH DELIRIUM AS TUMOUR-ASSOCIATED OEDEMA TRACKED INTO THE RIGHT TEMPORO-PARIETO-OCCIPITAL JUNCTION IN THE SETTING OF PRE-EXISTING ATROPHY FROM EXTERNAL BEAM RADIATION THERAPY (EBRT) AND PRIOR SURGICAL TEMPORAL LOBE RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993920 VISUALASE LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 9735542 00643169655935

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death