BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

    MDR report key: 10731270 · Received October 23, 2020

    Report

    Report Number
    2183959-2020-05010
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 23, 2020
    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

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED RETURN OF INCONTINENCE. THE DEVICE WAS FUNCTIONING PROPERLY, BUT THE PHYSICIAN DETERMINED DUE TO CUFF COMPRESSION ATROPHY, CUFF SHOULD BE REPLACED. PATIENT UNDERWENT A REPLACEMENT PROCEDURE OF HIS ARTIFICIAL URINARY SPHINCTER (AUS) FOUR YEARS AFTER IMPLANT. CUFF WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190276 AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404131 130916007 00878953003092

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R