BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 23196193 · Received October 1, 2025

    Report

    Report Number
    2124215-2025-67458
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    January 1, 2024
    Report Date
    October 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT EVENT DATE WAS NOT AVAILABLE, THEREFORE THE DATE 01/01/2024 WAS USED AS AN ESTIMATE, BASED ON THE REPORTED ONSET OCCURRING IN 2024. 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 UNIQUE IDENTIFIER (UDI) NUMBER AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS OF URINARY INCONTINENCE IS A KNOWN RISK ASSOCIATED WITH IMPLANTS OF THESE DEVICE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). 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 RECURRENT INCONTINENCE. A REVISION SURGERY WAS PERFORMED IN WHICH PHYSICIAN EXPLANTED OFF ALL 3 COMPONENTS. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307637 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R