BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 17100091 · Received June 9, 2023

    Report

    Report Number
    2124215-2023-27945
    Event Type
    Injury
    Date Received
    June 9, 2023
    Date of Event
    January 1, 2021
    Report Date
    June 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: RAI, A. (2021). PATIENT-REPORTED OUTCOMES MEASURES FROM 153 MEN TREATED WITH WATER VAPOUR THERMAL THERAPY REZUM) FOR SYMPTOMATIC BENIGN PROSTATE HYPERPLASIA. ABSTRACTS OF THE 2021 ASSOCIATION OF SURGEONS IN TRAINING INTERNATIONAL SURGICAL CONFERENCE. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS AND THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION DURING TREATMENT. THE REPORTED PATIENT SYMPTOM OF SEPSIS IS A KNOWN RISK ASSOCIATED WITH USE OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICES ARE NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCTS COULD BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CITATION: RAI, A. (2021). PATIENT-REPORTED OUTCOMES MEASURES FROM 153 MEN TREATED WITH WATER VAPOUR THERMAL THERAPY REZUM) FOR SYMPTOMATIC BENIGN PROSTATE HYPERPLASIA. ABSTRACTS OF THE 2021 ASSOCIATION OF SURGEONS IN TRAINING INTERNATIONAL SURGICAL CONFERENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC, VIA THE ATTACHED ARTICLE PUBLISHED IN THE ABSTRACTS OF THE 2021 ASSOCIATION OF SURGEONS IN TRAINING INTERNATIONAL SURGICAL CONFERENCE, THE STUDY RESULTS FROM A SINGLE TERTIARY CENTER. THE STUDY INCLUDED PATIENT-REPORTED OUTCOME MEASURES (PROMS) AND ADVERSE EVENTS FROM PATIENTS TREATED WITH REZUM. THE STUDY CONSISTED OF 153 PATIENTS WITH A HISTORY OF ACUTE URINARY RETENTION, PREVIOUS BPH SURGERY, PROSTATE CANCER OR PROSTATITIS. PROMS INCLUDING INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), IPSS-QUALITY OF LIFE (IPSS-QOL) AND THE INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF-S) WERE COMPARED BETWEEN BASELINE AND AT A SINGLE DISCRETE FOLLOW-UP PERIOD (INITIAL [4-6 MONTHS]; EARLY [7-22 MONTHS]; MEDIUM [13-18 MONTHS]; OR LATE [> 18 MONTHS]) USING STUDENTS T-TEST (SPSS V26.0; P < O.OS). THE RESULTS SHOWED THAT, COMPARED TO BASELINE, ALL MEAN IPSS AND IPP-QOL REDUCTIONS WERE SIGNIFICANT AND AT MEDIUM FOLLOW UP, PAIRED IPSS AND IPSS-QOL REDUCTIONS WERE SIGNIFICANT. ONE PATIENT REQUIRED ANOTHER PROCEDURE DUE TO PERSISTENT SYMPTOMS, AND ONE PATIENT EXPERIENCED POSTOPERATIVE UROSEPSIS (CLAVIEN-DINDO IL). THE STUDY CONCLUDED THAT WATER VAPOR THERAPY SHOWED DURABLE PATIENT REPORTED IMPROVEMENTS IN MOST MEN, WITH PRESERVATION OF PATIENT REPORTED ERECTILE FUNCTION. NO DE NOVO ERECTILE DYSFUNCTION WAS REPORTED AT THE TIME THE ARTICLE WAS PUBLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC, VIA THE ATTACHED ARTICLE PUBLISHED IN THE ABSTRACTS OF THE 2021 ASSOCIATION OF SURGEONS IN TRAINING INTERNATIONAL SURGICAL CONFERENCE, THE STUDY RESULTS FROM A SINGLE TERTIARY CENTER. THE STUDY INCLUDED PATIENT-REPORTED OUTCOME MEASURES (PROMS) AND ADVERSE EVENTS FROM PATIENTS TREATED WITH REZUM. THE STUDY CONSISTED OF 153 PATIENTS WITH A HISTORY OF ACUTE URINARY RETENTION, PREVIOUS BPH SURGERY, PROSTATE CANCER OR PROSTATITIS. PROMS INCLUDING INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), IPSS-QUALITY OF LIFE (IPSS-QOL) AND THE INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF-S) WERE COMPARED BETWEEN BASELINE AND AT A SINGLE DISCRETE FOLLOW-UP PERIOD (INITIAL [4-6 MONTHS]; EARLY [7-22 MONTHS]; MEDIUM [13-18 MONTHS]; OR LATE [GREATER THAN 18 MONTHS]) USING STUDENTS T-TEST (SPSS V26.0; P LESS THAN O.OS). THE RESULTS SHOWED THAT, COMPARED TO BASELINE, ALL MEAN IPSS AND IPP-QOL REDUCTIONS WERE SIGNIFICANT AND AT MEDIUM FOLLOW UP, PAIRED IPSS AND IPSS-QOL REDUCTIONS WERE SIGNIFICANT. ONE PATIENT REQUIRED ANOTHER PROCEDURE DUE TO PERSISTENT SYMPTOMS, AND ONE PATIENT EXPERIENCED POSTOPERATIVE UROSEPSIS (CLAVIEN-DINDO IL). THE STUDY CONCLUDED THAT WATER VAPOR THERAPY SHOWED DURABLE PATIENT REPORTED IMPROVEMENTS IN MOST MEN, WITH PRESERVATION OF PATIENT REPORTED ERECTILE FUNCTION. NO DE NOVO ERECTILE DYSFUNCTION WAS REPORTED AT THE TIME THE ARTICLE WAS PUBLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436013 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| R