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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Cognitive Changes (2551); Weight Changes (2607); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 09/27/2019
Event Type  Injury  
Manufacturer Narrative
Referred to treating physician by: dr. (b)(6). Treating physician: dr. (b)(6). Facility location is unknown.
 
Event Description
It was reported by the patient that on (b)(6) 2019, he consulted with his urologist the possibility of undergoing water vapor therapy with rezum. During the consultation, the patient s prostate was confirmed to measured 133g. The urologist indicated that water vapor therapy with rezum is approved by fda for up to 80g. Prostate gland. Prior to the procedure, preliminary cystoscopy noted obstruction, and also extension of the patient s prostate into the bladder which the urologist indicated it could be eliminated with the rezum procedure. The patient underwent the water vapor therapy with rezum on (b)(6) 2019. During the procedure under local anesthesia, the patient experienced pain, and was screaming. The patient was released after the procedure. While driving home, the patient began to experience bladder spasms. Apparently, the medical staff did not provide post operation medications to alleviate bladder spasms. Approximately two months following the index procedure, the patient began to urinate frequently and dribble urine. The patient followed-up with a different physician and prescribed oxybutynin and physical therapy. In addition, the physician suggested the patient to go back to his treating urologist. The patient soon began to experience painful urination and frequently urinating every 10-15minutes. The patient visited the (b)(6) emergency room; however, the er physician refused to see him and instead recommended to see his treating urologist. On (b)(6) 2021 the patient was able to visit his urologist for a cystoscopy. The patient was unable to explain all the symptoms experienced as the urologist interrupted him. During the cystoscopy, the urologist continued to state that there were no obstructions. However, per the urologist previous report, there were obstructions and extension of the patient s prostate was protruding into the bladder. The patient followed up with a physiotherapist for the frequent urination and a psychiatrist for the pain, as suggested by the treating urologist. The patient indicated that the biggest issue along with the pain, was not being able to sleep due to the frequent urination and pain. Due to the lack of sleep, the patient loss over 20lbs. And developed extreme brain fog, which made it impossible to work or perform basic daily life functions. The patient sought out another urologist around (b)(6) 2021. The urologist performed a holmium laser enucleation of the prostate (holep) procedure, and the patient reported that he has seen improvement after the holep treatment.
 
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Brand NameREZUM
Type of DeviceUNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
4089353452
MDR Report Key12059234
MDR Text Key258102664
Report Number2124215-2021-17332
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/24/2021 Patient Sequence Number: 1
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