BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 10101540 · Received May 29, 2020

    Report

    Report Number
    1723170-2020-01544
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    April 12, 2020
    Report Date
    May 29, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT NOT PROVIDED IN JOURNAL ARTICLE. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE DATE THE ARTICLE WAS PUBLISHED ONLINE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM PRODUCT NUMBER AND SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: GAMBOA, N.T., KARSY, M., IYER, R.R. ET AL. STEREOTACTIC LASER INTERSTITIAL THERMAL THERAPY FOR BRAINSTEM CAVERNOUS MALFORMATIONS: TWO PRELIMINARY CASES. ACTA NEUROCHIR (2020). HTTPS://DOI.ORG/10.1007/S00701-020-04316-7. SUMMARY: BRAINSTEM CAVERNOUS MALFORMATIONS (CMS) OFTEN HAVE HIGH HEMORRHAGE RATES AND SIGNIFICANT POST HEMORRHAGE MORBIDITY. THE AUTHORS PRESENT TWO CASES IN WHICH MAGNETIC RESONANCE THERMOGRAPHY-GUIDED LASER INTERSTITIAL THERAPY WAS USED FOR TREATMENT OF PONTINE CMS AFTER RECURRENT HEMORRHAGE. BOTH PATIENTS SHOWED SIGNIFICANT SYMPTOMATIC IMPROVEMENT AND WERE HEMORRHAGE-FREE AT 12- AND 6-MONTH FOLLOW-UP, RESPECTIVELY. EACH HAD RADIOGRAPHIC EVIDENCE OF LESION INVOLUTION ON SERIAL FOLLOW-UP IMAGING. THESE EARLY RESULTS DEMONSTRATE THIS TREATMENT MODALITY MAY BE TECHNICALLY SAFE; HOWEVER, LARGER CASE NUMBERS AND LONGER FOLLOW UP ARE NEEDED TO DEMONSTRATE EFFICACY. REPORTED EVENT: A (B)(6) YEAR-OLD WOMAN WITH A HISTORY OF MULTIPLE CEREBRAL CMS AND ONE PRIOR RESECTION OF A LEFT OCCIPITAL LOBE CM PRESENTED AFTER A NEW 1.1-CM RIGHT PONTINE CM HEMORRHAGE RESULTED IN WORSENING HORIZONTAL DIPLOPIA (RIGHT CRANIAL NERVE VI PALSY), LEFT FACIAL NUMBNESS, AND PARESTHESIAS. THE PATIENT UNDERWENT A RIGHT FRONTAL TRANSCAPSULAR APPROACH, TYPICALLY USED FOR PEDIATRIC BRAIN STEM BIOPSIES, FOR LITT TREATMENT. POSTOPERATIVELY, SHE SHOWED SOME WORSENED LEFT-SIDED FACIAL NUMBNESS, LEFT-SIDED WEAKNESS, AND DYSARTHRIA THAT GRADUALLY IMPROVED. EARLY POSTOPERATIVE IMAGING DISCLOSED A SMALL ZONE OF INJURY IN THE POSTERIOR INTERNAL CAPSULE AND CEREBRAL PEDUNCLE RELATED TO THE FIBER TRAJECTORY AND SOME CIRCUMFERENTIAL EDEMA AROUND THE CM. HER POSTOPERATIVE CONVALESCENCE REQUIRED INPATIENT MEDICAL REHABILITATION. SHE HAS BEEN MONITORED FOR 18 MONTHS AND HAS SHOWED SUBSTANTIAL IMPROVEMENT IN HER NEUROLOGICAL EXAMINATION¿NOTABLY, RESOLVED DIPLOPIA AND LEFT FACIAL NUMBNESS WITH SOME RESIDUAL LEFT-SIDED WEAKNESS AND ATAXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566990 MEDTRONIC NAVIGATION LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention