BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 ARTIFICIAL URINARY SPHINCTER

    MDR report key: 22237820 · Received June 17, 2025

    Report

    Report Number
    2124215-2025-39902
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953003092
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR PUMP FGS IZ IS (B)(4). UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR BALLOON FGS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER EXPERIENCED EROSION AT THE URETHRAL CUFF SITE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE CUFF WAS EXPLANTED. THE URETHRA WAS ALLOWED TIME TO RECOVER, AND A SUBSEQUENT SURGERY WAS SCHEDULED TO IMPLANT A NEW DEVICE AT A DIFFERENT CUFF SITE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434776 AMS 800 ARTIFICIAL URINARY SPHINCTER DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404131 1100520210 00878953003092

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| H BALLOON FGS LOT 1100594417, UPN 72400024| PUMP FGS IZ LOT 1100564916, UPN 72404127