BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROBLATE® SYSTEM

    MDR report key: 23436631 · Received October 31, 2025

    Report

    Report Number
    3009970070-2025-00016
    Event Type
    Death
    Date Received
    October 31, 2025
    Date of Event
    November 18, 2024
    Report Date
    October 31, 2025
    Manufacturer
    MONTERIS MEDICAL
    Product Code
    GEX
    UDI-DI
    00816589021080
    PMA / PMN Number
    K193375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INFECTIONS ARE DOCUMENTED PERIOPERATIVE RISKS FOR BRAIN SURGERIES SUCH AS MRI-GUIDED NEUROSURGICAL ABLATION. THIS DOCUMENTATION IS AVAILABLE IN THE NEUROBLATE IFU AND IN MONTERIS' INTERNAL RISK MANAGEMENT FILES. NO MALFUNCTION WAS ALLEGED; THEREFORE, NO DEVICE EVALUATION WAS PERFORMED.

    Description of Event or Problem · 0

    ACCORDING TO A REMASTER SAE FORM, IT WAS REPORTED ON POST-LITT PROCEDURE DAY 18, THE PATIENT PRESENTED TO THE ER DUE TO DECREASED APPETITE AND INCREASED GENERALIZED WEAKNESS. THE PATIENT WAS TOO WEAK TO ATTEND HER ONCOLOGY APPOINTMENT, AND IT WAS RECOMMENDED THAT SHE GO IN. UPON ARRIVAL, HER HEART RATE WAS IN THE 130S, AND HER SYSTOLIC BLOOD PRESSURE WAS 69-78. SHE WAS ADMITTED TO THE ICU FOR HEMODYNAMIC MANAGEMENT. CHEST IMAGING INDICATED MODERATE TO LARGE RIGHT PLEURAL EFFUSION WITH MILD TO MODERATE LAYERING LEFT PLEURAL EFFUSION. BLOOD CULTURE CAME BACK POSITIVE FOR HAEMOPHILUS INFLUENZAE, AND URINE CULTURE WAS POSITIVE FOR KLEBSIELLA PNEUMONIAE. ON POST-STUDY PROCEDURE DAY 27, THE PATIENT REMAINED AFEBRILE AND HEMODYNAMICALLY STABLE. WHITE BLOOD CELL COUNT CONTINUED TO INCREASE, AND CHEST IMAGING SHOWED LARGE RIGHT PLEURAL EFFUSION WITH NEAR COMPLETE COMPRESSIVE ATELECTASIS. CT ALSO SHOWED DILATED STOMACH AND DISTAL SMALL BOWEL WITH DECOMPRESSED COLON SUGGESTIVE OF BOWEL OBSTRUCTION. THE PATIENT REMAINED ON ANTIBIOTICS WITHOUT IMPROVEMENT. ON POST-STUDY PROCEDURE DAY 28, PATIENT HAD A COUGH AND DECREASED SATURATIONS OVERNIGHT. WHITE BLOOD CELL COUNT CONTINUED TO INCREASE WITHOUT SIGNS OF INFECTION. SHE REQUIRED INCREASED OXYGEN. SHE WAS STARTED ON A CLEAR, LIQUID DIET AND EXPRESSED THAT SHE DID NOT WANT TO UNDERGO ANOTHER THORACENTESIS. SHE TRANSITIONED TO INPATIENT HOSPICE. ON POST-STUDY PROCEDURE DAY 29 (B)(6) 2024, THE PATIENT "GRADUALLY DETERIORATED AND DIED PEACEFULLY". THE SAE WAS DEEMED BY THE TREATING PHYSICIAN TO BE NOT RELATED TO THE LITT DEVICE OR LITT PROCEDURE; HOWEVER, ON (B)(6) 2025 THE REMASTER SAFETY COMMITTEE DEEMED THE EVENT AS POSSIBLY RELATED TO THE LITT PROCEDURE, AS WELL AS POSSIBLY RELATED TO THE SURGICAL PROCEDURE AND POSSIBLY RELATED TO STEROID THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298732 NEUROBLATE® SYSTEM NEUROBLATE® SYSTEM GEX MONTERIS MEDICAL 20980 00816589021080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| D