BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 20152098 · Received September 5, 2024

    Report

    Report Number
    2124215-2024-54276
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    April 30, 2021
    Report Date
    September 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3 DATE OF EVENT: APPROXIMATED. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE A KNOWN RISK ASSOCIATED WITH IMPLANT OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. CAMPOBASSO, D., SIENA, G., CHIODINI, P., CONTI, E., FRANZOSO, F., & MARUZZI, D. (2022). COMPOSITE URINARY AND SEXUAL OUTCOMES AFTER REZUM: AN ANALYSIS OF PREDICTIVE FACTORS FROM AN ITALIAN MULTI-CENTRIC STUDY. PROSTATE CANCER AND PROSTATIC DISEASES. HTTPS://DOI.ORG/10.1038/S41391-022-00587-6.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A STUDY PUBLISHED IN THE PROSTATE CANCER AND PROSTATIC DISEASES JOURNAL THAT A MULTICENTER, AND A RETROSPECTIVE STUDY WAS CONDUCTED TO ANALYZE THE PREDICTIVE FACTORS OF COMPOSITE URINARY AND SEXUAL OUTCOMES AFTER A REZUM TREATMENT. THE MEDICAL RECORD OF 262 PATIENTS WHO UNDERWENT A WATER VAPOR THERAPY PROCEDURE IN SEVEN DIFFERENT ITALIANS INSTITUTIONS WERE AVAILABLE. THE STUDY SPANNED FROM JUNE 2019 TO APRIL 2021 AND UTILIZED A MEDIAN FOLLOW UP PERIOD OF 11 MONTHS AFTER PROCEDURE. THE STUDY MEASURED THE INTERNATIONAL PROSTATE SYMPTOMS SCORE (IPSS), IPSS QUALITY OF LIFE (QOL), THE OVERACTIVE BLADDER QUESTIONNAIRE-SHORT FORM (OAB-Q SF) SCORE, AND THE INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF-5). NO EARLY OR LATE SERIOUS ADVERSE EVENTS (CLAVIEN III-IV) OCCURRED. EARLY COMPLICATIONS REPORTED INCLUDED FOUR CASES OF CLOT RETENTION, AND ONE PATIENT REQUIRING BLOOD TRANSFUSION. URGE INCONTINENCE WAS REPORTED BY 6 PATIENTS, WHILE NO CASES OF STRESS URINARY INCONTINENCE OCCURRED. ONLY FOUR PATIENTS REQUIRED SURGICAL RETREATMENT DUE TO TREATMENT FAILURE. AFTER THE PROCEDURE, THE ANTEGRADE EJACULATION RATE WAS 78.2%, WITH A 21.7% INCREASE. OTHER EARLY AND LATE COMPLICATIONS WERE ALSO REPORTED, SUCH AS: ACUTE URINARY RETENTION, DYSURIA, URINARY TRACT INFECTION, AND HEMATURIA. FUNCTIONAL OUTCOMES AT THE LATEST FOLLOW UP SHOWED SUSTAINED IMPROVEMENTS IN PEAK FLOW, PVR, OAB-Q SF, QOL, IPSS AND ANTEGRADE EJACULATION. THIS COMPREHENSIVE STUDY CONFIRMED THAT THE REZUM TREATMENT IS EFFECTIVE AND SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035765 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other