BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AQM DEVICE

    MDR report key: 8321770 · Received February 8, 2019

    Report

    Report Number
    1226420-2019-00017
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 8, 2019
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ARTICLE TITLE: COST-EFFECTIVENESS OF A RADIO FREQUENCY HEMOSTATIC SEALER (RFHS) IN ADULT SPINAL DEFORMITY SURGERY METHODS: IN AN OBSERVATIONAL COHORT STUDY, WE COMPARED TRANSFUSION REQUIREMENTS IN 30 PATIENTS UNDERGOING SURGERY FOR ADULT SPINAL DEFORMITY USING THE RFHS WITH THAT OF A HISTORICAL CONTROL GROUP OF 30 PATIENTS IN WHICH TRADITIONAL HEMOSTASIS WAS OBTAINED WITH BIPOLAR ELECTROCAUTERY AND MATCHED THEM FOR BLOOD LOSS RELATED VARIABLES. TOTAL EXPENSE TO THE HOSPITAL FOR THE RFHS, LABORATORY EXPENSES, AND BLOOD TRANSFUSIONS WAS USED FOR COST CALCULATIONS. THE INCREMENTAL COST-EFFECTIVENESS RATIO WAS CALCULATED USING THE NUMBER OF BLOOD TRANSFUSIONS AVOIDED AS THE EFFECTIVENESS PAYOFF. RESULTS: USING A MULTIVARIABLE LINEAR REGRESSION MODEL, WE FOUND THAT ONLY ESTIMATED BLOOD LOSS (EBL) WAS AN INDEPENDENT SIGNIFICANT PREDICTOR OF TRANSFUSION REQUIREMENT IN BOTH GROUPS. WE EVALUATED THE VARIABLES OF AGE, EBL, TIME DURATION OF SURGERY, PREOPERATIVE HEMOGLOBIN, HEMOGLOBIN NADIR DURING SURGERY, BODY MASS INDEX, LENGTH OF STAY, AND NUMBER OF LEVELS OPERATED ON. MEAN EBL WAS GREATER IN THE CONTROL GROUP (2201 VS. 1416 ML, P [ 0.0099). THE NUMBER OF TRANSFUSIONS ALSO WAS GREATER IN THE CONTROL GROUP (14.5 VS. 6.5, P[0.0008). IN THE COST-EFFECTIVENESS ANALYSIS, WE FOUND THAT THE RFHS COST (B)(6) MORE (COMPARED WITH NOT USING THE RFHS) TO AVOID 1 UNIT OF BLOOD TRANSFUSION. THE RFHS GROUP MEAN: 64.7 YEARS OF AGE ADVERSE EFFECTS: NUMBER OF BLOOD PRODUCT TRANSFUSED: 6.5 MEAN THE RFHS GROUP: OUT OF 21 FEMALES, 2 PATIENT'S EXPERIENCED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112602 UNKNOWN AQM DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK AQM DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention