BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 ARTIFICIAL URINARY SPHINCTER

    MDR report key: 25037815 · Received April 29, 2026

    Report

    Report Number
    2124215-2026-23313
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    December 1, 2025
    Report Date
    April 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953003092
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER: 72400024, BATCH/LOT NUMBER: 1100349797, MODEL/CATALOG DESCRIPTION: BALLOON FGS 61-70 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404127, BATCH/LOT NUMBER: 1100346707, MODEL/CATALOG DESCRIPTION: CONTROL PUMP FGS IZ, UNIQUE IDENTIFIER (UDI) #: (01)00878953003078(17)250816(10)1100346707(B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORTED DEVICE PERFORMANCE ALLEGATION. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF EROSION WAS DEFINED IN THE PRODUCT RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) PRESENTED WITH EROSION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH TIME THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60042 AMS 800 ARTIFICIAL URINARY SPHINCTER DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404131 1100318085 00878953003092

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention| H