BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 ARTIFICIAL URINARY SPHINCTER

    MDR report key: 23245231 · Received October 8, 2025

    Report

    Report Number
    2124215-2025-70687
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    June 25, 2024
    Report Date
    October 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4). CONCOMITANT PRODUCT UDI FOR BALLOON 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 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'S ARTIFICIAL URINARY SPHINCTER (AUS) DIDN'T PROVIDE SATISFACTORY RELIEF SINCE THE INITIAL IMPLANT. AFTER EXAMINATION, WAS IDENTIFIED THAT THE CUFF WAS TOO LARGE FOR THE PATIENT. A SURGICAL PROCEDURE WAS PERFORMED TO EXPLANT THE DEVICE DUE TO THE SIZING ISSUE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585925 AMS 800 ARTIFICIAL URINARY SPHINCTER DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404133 1100219548

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Hospitalization| R BALLOON: UPN: 72400024 / LOT: 1100469578.| PUMP: UPN: 72404127 / LOT: 1100505380.