BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 21965075 · Received May 5, 2025

    Report

    Report Number
    2124215-2025-28830
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    November 24, 2024
    Report Date
    June 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT. THE STUDY STARTED ON JANUARY 2019, THE EVENT DATE WAS APPROXIMATED TO THE FIRST DATE OF THE MONTH. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WONG K, KOP M M, LEE F (NOVEMBER 26, 2024) COMPARING PATIENT-REPORTED OUTCOMES FOLLOWING THE MINIMALLY INVASIVE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)-RELATED LOWER URINARY TRACT SYMPTOMS: REZUM VERSUS UROLIFT. CUREUS 16(11): E74532. DOI 10.7759/CUREUS.74532.

    Additional Manufacturer Narrative · 0

    B3 WAS CORRECTED TO THE ARTICLE PUBLICATION DATE. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WONG K, KOP M LEE F (NOVEMBER 26, 2024) COMPARING PATIENT-REPORTED OUTCOMES FOLLOWING THE MINIMALLY INVASIVE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)-RELATED LOWER URINARY TRACT SYMPTOMS: REZUM VERSUS UROLIFT. CUREUS 16(11): E74532. DOI 10.7759/CUREUS.74532.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE CEREUS JOURNAL THAT A STUDY WAS CONDUCTED TO COMPARE PATIENT-REPORTED OUTCOMES OF MINIMALLY INVASIVE TREATMENTS FOR LOWER URINARY TRACT SYMPTOMS (LUTS) SECONDARY TO BENIGN PROSTATIC HYPERPLASIA (BPH), SPECIFICALLY TRANSURETHRAL WATER VAPOR THERAPY (REZUM) AND PROSTATIC URETHRAL LIFT (UROLIFT), BETWEEN (B)(6) 2019 AND (B)(6) 2022. OUTCOMES WERE COMPARED BETWEEN 80 REZUM-TREATED PATIENTS AND 68 UROLIFTTREATED PATIENTS. PATIENTS WHO UNDERWENT REZUM, REPORTED WORSE INITIAL URINARY SYMPTOMS AND BETTER POST-PROCEDURAL URINARY SYMPTOMS AND QUALITY OF LIFE COMPARED TO THOSE WHO UNDERWENT UROLIFT. TWO PATIENTS WHO UNDERWENT REZUM REQUIRED SECONDARY PROCEDURES, ONE REZUM AND ONE TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), WHILE A TOTAL OF FIVE PATIENTS WHO UNDERWENT UROLIFT REQUIRED SECONDARY PROCEDURES (FIVE TURP). THIS REPORT REFERS TO THE PATIENT WHO REQUIRED AN TURP FOLLOWING REZUM TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE CEREUS JOURNAL THAT A STUDY WAS CONDUCTED TO COMPARE PATIENT-REPORTED OUTCOMES OF MINIMALLY INVASIVE TREATMENTS FOR LOWER URINARY TRACT SYMPTOMS (LUTS) SECONDARY TO BENIGN PROSTATIC HYPERPLASIA (BPH), SPECIFICALLY TRANSURETHRAL WATER VAPOR THERAPY (REZUM) AND PROSTATIC URETHRAL LIFT (UROLIFT), BETWEEN JANUARY 2019 AND JUNE 2022. OUTCOMES WERE COMPARED BETWEEN 80 REZUM-TREATED PATIENTS AND 68 UROLIFTTREATED PATIENTS. PATIENTS WHO UNDERWENT REZUM, REPORTED WORSE INITIAL URINARY SYMPTOMS AND BETTER POST-PROCEDURAL URINARY SYMPTOMS AND QUALITY OF LIFE COMPARED TO THOSE WHO UNDERWENT UROLIFT. TWO PATIENTS WHO UNDERWENT REZUM REQUIRED SECONDARY PROCEDURES, ONE REZUM AND ONE TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), WHILE A TOTAL OF FIVE PATIENTS WHO UNDERWENT UROLIFT REQUIRED SECONDARY PROCEDURES (FIVE TURP). THIS COMPLAINT REFERS TO THE PATIENT WHO REQUIRED AN TURP FOLLOWING REZUM TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98110 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| H