BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROBLATE

    MDR report key: 4900170 · Received July 8, 2015

    Report

    Report Number
    3009970070-2015-00005
    Event Type
    Death
    Date Received
    July 8, 2015
    Date of Event
    May 18, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MONTERIS MEDICAL CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K143457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO DEVICE MALFUNCTIONS WERE REPORTED. A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS WAS PERFORMED. THE DEVICE PASSED ALL FUNCTIONAL TESTING AND MET ALL PERFORMANCE SPECIFICATIONS. THE STERILE CYCLE WAS FOUND TO BE CONFORMING, THE ENDOTOXIN TEST ( LAL) PASSED, AND THE BIOLOGICAL INDICATOR RESULTS WERE CONFORMING. THERE IS NO INDICATION OF NONCONFORMANCE FOR THIS DEVICE. MONTERIS CONCURS WITH THE SURGEON'S ASSESSMENT THAT THE PATIENT'S DEATH WAS DEFINITELY RELATED TO UNDERLYING DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ADVERSE REPORT FOR THE LAASR STUDY, THAT A TERMINALLY ILL PATIENT WITH NUMEROUS UNDERLYING DISEASES INCLUDING DIABETES MELLITUS, COPD, HYPERTENSION, PRE-EXISTING PULMONARY EMBOLI, PNEUMONIA, OBESITY, STAGE IV SMALL CELL LUNG CANCER, AND METASTATIC BRAIN CANCER, EXPIRED DUE TO PULMONARY EMBOLI ON (B)(6) 2015. A NEUROBLATE PROCEDURE FOR PALLIATIVE CARE HAD BEEN PERFORMED ON (B)(6) 2015. THE SURGEON TOOK THE PATIENT OFF ANTICOAGULANTS FOR THE NEUROBLATE PROCEDURE. THE SURGEON STATED THAT THE REMOVAL OF ANTICOAGULANTS MAY HAVE CONTRIBUTED TO THE MANIFESTATION OF THE PULMONARY EMBOLI 12 DAYS LATER. THE SURGEON ALSO STATED THAT THE PATIENT EXPERIENCED SEIZURES WHICH MAY HAVE BEEN THE RESULT OF CORTICAL IRRITATION FOLLOWING THE NEUROBLATE PROCEDURE. MULTIPLE UNDERLYING DISEASES, AND PNEUMONIA LIKELY BROUGHT ON BY SEIZURE-RELATED DECREASED CONSCIOUSNESS WERE ALSO REPORTED. THE ANESTHESIA PLAN FOR THIS PATIENT STATED "PATIENT WITH SEVERE SYSTEMIC DISEASE THAT IS A CONSTANT THREAT TO LIFE". A COMPLETE LIST OF COMORBIDITIES IS PROVIDED IN THE ATTACHED MEDICAL RECORD. THE ADVERSE EVENT FORM WRITTEN BY THE SURGEON STATES THAT THE PATIENT'S DEATH WAS "DEFINITELY" RELATED TO UNDERLYING DISEASE. THE ADVERSE EVENT FORMS ARE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443966 NEUROBLATE POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORPORATION NBP-001-01

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death