REZUM
Report
- Report Number
- 2124215-2025-82697
- Event Type
- Injury
- Date Received
- November 19, 2025
- Date of Event
- October 24, 2025
- Report Date
- December 26, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BABAR, M., LOLOI, J., TANG, K., SINGH, S., INES, M., PATEL, R. D., IQBAL, N., & CIATTO, M. (2023). A RETROSPECTIVE REVIEW OF THE REZUM SYSTEM: TREATMENT FOR BENIGN PROSTATIC HYPERPLASIA IN MEN WITH MILD, MODERATE, AND SEVERE LOWER URINARY TRACT SYMPTOMS. CAN UROL ASSOC, 83(7), 713-721. HTTPS://DOI.ORG/10.1002/PROS.24508.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BABAR, M., LOLOI, J., TANG, K., SINGH, S., INES, M., PATEL, R. D., IQBAL, N., & CIATTO, M. (2023). A RETROSPECTIVE REVIEW OF THE REZUM SYSTEM: TREATMENT FOR BENIGN PROSTATIC HYPERPLASIA IN MEN WITH MILD, MODERATE, AND SEVERE LOWER URINARY TRACT SYMPTOMS. CAN UROL ASSOC, 83(7), 713-721. HTTPS://DOI.ORG/10.1002/PROS.24508. 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 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.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE CAN UROL ASSOC J THAT A RETROSPECTIVE REVIEW WAS CONDUCTED TO REPORT 12-MONTH RESULTS FROM TWO UROLOGISTS IN A SINGLE CLINICAL SETTING FOR MEN WITH MILD, MODERATE, AND SEVERE LOWER URINARY TRACT SYMPTOMS (LUTS). A TOTAL OF 152 MEN, AGED 38-82 YEARS, WITH INTERNATIONAL PROSTATE SYMPTOM SCORES (IPSS) 2 AND PROSTATE VOLUMES (PVS) FROM 18-111 CC, WERE INCLUDED IN A RETROSPECTIVE REVIEW OF THE REZUM SYSTEM. IPSS, QUALITY OF LIFE (QOL), AND ADVERSE EVENTS (AES) WERE PROACTIVELY COLLECTED OVER THE PHONE. THE PRIMARY ENDPOINT WAS TO EVALUATE IPSS AND QOL REDUCTION FOR MEN WITH MILD, MODERATE, AND SEVERE LUTS AT SIX MONTHS. THEY WERE ASSESSED FOR AES, BPH MEDICATION USAGE, AND PV REDUCTION OVER 12 MONTHS. FOR MEN WITH MODERATE LUTS, MEAN IPSS AND QOL DECREASED FROM BASELINE (14.0, 3.9) UP TO 12 MONTHS (9.4, 2.1), RESPECTIVELY. SIMILARLY, FOR MEN WITH SEVERE LUTS, MEAN IPSS AND QOL DECREASED FROM BASELINE (25.2, 4.4) UP TO 12 MONTHS (11.5, 2.7), RESPECTIVELY. FOR MEN WITH MILD LUTS, MEAN IPSS INCREASED FROM BASELINE (5.2) TO ONE MONTH (10.1) AND THEN SHOWED NO SIGNIFICANT CHANGE UP TO 12 MONTHS (5.1). ADDITIONALLY, MEAN QOL SHOWED NO SIGNIFICANT CHANGE FROM BASELINE (2.9) TO ONE MONTH (3.0) BUT DECREASED FROM BASELINE AT THREE, SIX, AND 12 MONTHS (2.1, 1.0, 1.2), RESPECTIVELY. AT SIX MONTHS, THE MEAN PV REDUCTION FROM BASELINE FOR ALL MEN WAS 30%, AND 68% STOPPED ALL BPH MEDICATIONS. NO SIGNIFICANT CHANGE IN AE OCCURRENCE WAS OBSERVED BETWEEN MEN WITH MILD AND MODERATE-SEVERE LUTS. SOME OF THE OBSERVED ADVERSE EVENTS WERE GROSS HEMATURIA, PENILE BURNING, PENILE PAIN, DYSURIA, SLOUGHING, URINARY RETENTION, URINARY TRACT INFECTION, ANORGASMIA AND ANEJACULATION. BASED ON IMPROVEMENTS IN IPSS AND QOL, THE REZUM SYSTEM EFFECTIVELY TREATS MEN WITH MODERATE AND SEVERE LUTS. IPSS SHOWED NO CHANGE FROM BASELINE TO SIX MONTHS FOR MEN WITH MILD LUTS; HOWEVER, QOL IMPROVED AT SIX MONTHS FOR MEN WITH MILD LUTS, AND AE OCCURRENCE WAS CONSISTENT ACROSS ALL LUTS CATEGORIES. THEREFORE, THE REZUM SYSTEM IS ALSO A VIABLE TREATMENT FOR MEN WITH MILD LUTS.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE CAN UROL ASSOC J THAT A RETROSPECTIVE REVIEW WAS CONDUCTED TO REPORT 12-MONTH RESULTS FROM TWO UROLOGISTS IN A SINGLE CLINICAL SETTING FOR MEN WITH MILD, MODERATE, AND SEVERE LOWER URINARY TRACT SYMPTOMS (LUTS). A TOTAL OF 152 MEN, AGED 38-82 YEARS, WITH INTERNATIONAL PROSTATE SYMPTOM SCORES (IPSS) 2 AND PROSTATE VOLUMES (PVS) FROM 18-111 CC, WERE INCLUDED IN A RETROSPECTIVE REVIEW OF THE REZUM SYSTEM. IPSS, QUALITY OF LIFE (QOL), AND ADVERSE EVENTS (AES) WERE PROACTIVELY COLLECTED OVER THE PHONE. THE PRIMARY ENDPOINT WAS TO EVALUATE IPSS AND QOL REDUCTION FOR MEN WITH MILD, MODERATE, AND SEVERE LUTS AT SIX MONTHS. THEY WERE ASSESSED FOR AES, BPH MEDICATION USAGE, AND PV REDUCTION OVER 12 MONTHS. FOR MEN WITH MODERATE LUTS, MEAN IPSS AND QOL DECREASED FROM BASELINE (14.0, 3.9) UP TO 12 MONTHS (9.4, 2.1), RESPECTIVELY. SIMILARLY, FOR MEN WITH SEVERE LUTS, MEAN IPSS AND QOL DECREASED FROM BASELINE (25.2, 4.4) UP TO 12 MONTHS (11.5, 2.7), RESPECTIVELY. FOR MEN WITH MILD LUTS, MEAN IPSS INCREASED FROM BASELINE (5.2) TO ONE MONTH (10.1) AND THEN SHOWED NO SIGNIFICANT CHANGE UP TO 12 MONTHS (5.1). ADDITIONALLY, MEAN QOL SHOWED NO SIGNIFICANT CHANGE FROM BASELINE (2.9) TO ONE MONTH (3.0) BUT DECREASED FROM BASELINE AT THREE, SIX, AND 12 MONTHS (2.1, 1.0, 1.2), RESPECTIVELY. AT SIX MONTHS, THE MEAN PV REDUCTION FROM BASELINE FOR ALL MEN WAS 30%, AND 68% STOPPED ALL BPH MEDICATIONS. NO SIGNIFICANT CHANGE IN AE OCCURRENCE WAS OBSERVED BETWEEN MEN WITH MILD AND MODERATE-SEVERE LUTS. SOME OF THE OBSERVED ADVERSE EVENTS WERE GROSS HEMATURIA, PENILE BURNING, PENILE PAIN, DYSURIA, SLOUGHING, URINARY RETENTION, URINARY TRACT INFECTION, ANORGASMIA AND ANEJACULATION. BASED ON IMPROVEMENTS IN IPSS AND QOL, THE REZUM SYSTEM EFFECTIVELY TREATS MEN WITH MODERATE AND SEVERE LUTS. IPSS SHOWED NO CHANGE FROM BASELINE TO SIX MONTHS FOR MEN WITH MILD LUTS; HOWEVER, QOL IMPROVED AT SIX MONTHS FOR MEN WITH MILD LUTS, AND AE OCCURRENCE WAS CONSISTENT ACROSS ALL LUTS CATEGORIES. THEREFORE, THE REZUM SYSTEM IS ALSO A VIABLE TREATMENT FOR MEN WITH MILD LUTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2310276 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |