BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 ARTIFICIAL URINARY SPHINCTER

    MDR report key: 23191690 · Received October 1, 2025

    Report

    Report Number
    2124215-2025-68808
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT UDI FOR BALLOON IS (B)(4). CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4). THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOM OF INCONTINENCE IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRING INCONTINENCE, AND THE CUFF WAS SUSPECTED TO BE TOO LARGE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE PREVIOUS CUFF WAS REMOVED AND A SMALLER CUFF WAS PLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674328 AMS 800 ARTIFICIAL URINARY SPHINCTER DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404132 1100528115

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R