BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 12032629 · Received June 21, 2021

    Report

    Report Number
    2124215-2021-16946
    Event Type
    Death
    Date Received
    June 21, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING RECURRENT URINARY INCONTINENCE FOR ABOUT 3 MONTHS (PROGRESSIVELY LEAKING). ENDOSCOPY SHOWED THAT THE OCCLUSIVE CUFF WAS NOT-FULLY CLOSING TO KEEP URINE IN THE BLADDER, AND THE PRESSURE-REGULATING BALLOON ATTACHED TO THE CUFF WAS NOT COMPLETELY EMPTY. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THE IMPLANTED ARTIFICIAL URINARY SPHINCTER (AUS). FOLLOWING THE REMOVAL OF THE AUS IMPLANT, A TRANSURETHRAL RESECTION OF THE BLADDER WAS PERFORMED. THERE WAS NO RE-IMPLANTATION OF ANOTHER AUS. IT WAS NOTED THAT THE PATIENT PASSED AWAY OF AN UNSPECIFIED CAUSE POST-PROCEDURE DURING HOSPITALIZATION. BOSTON SCIENTIFIC IS IN THE PROCESS OF ATTEMPTING TO OBTAIN FURTHER INFORMATION FROM THE HEALTHCARE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927671 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| H| R