BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 ARTIFICIAL URINARY SPHINCTER

    MDR report key: 23286850 · Received October 15, 2025

    Report

    Report Number
    2124215-2025-69016
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953003122
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR BALLOON IS (B)(4) UDI FIELD (D4) 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 SYMPTOMS OF URINARY TRACT INFECTION, PAIN AND URINARY INCONTINENCE ARE KNOWN RISKS ASSOCIATED WITH IMPLANT 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 AND PAIN AFTER A URINARY TRACT INFECTION. A REVISION SURGERY WAS PERFORMED IN WHICH PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187433 AMS 800 ARTIFICIAL URINARY SPHINCTER DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404134 1100381996 00878953003122

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention| H BALLOON LOT 1100491425, UPN 72400024.| PUMP LOT 1100457228, UPN 72404127.