BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 9192508 · Received October 15, 2019

    Report

    Report Number
    2183959-2019-66814
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    January 1, 1987
    Report Date
    October 15, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE COMPLAINT COMPONENT WAS NOT RETURNED FOR ANALYSIS, AND THE PRODUCT RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THE REPORTED ALLEGATIONS COULD NOT BE CONFIRMED. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA OR SCAR IS REQUIRED.

    Description of Event or Problem · 1

    PER LITERATURE, IT WAS REPORTED THAT A RETROSPECTIVE COHORT REVIEW WAS PERFORMED TO EVALUATE THE IMPACT OF DIABETES MELLITUS AND OBESITY ON ARTIFICIAL URINARY SPHINCTER (AUS) OUTCOMES. FROM 1987 TO 2011, 568 OF 954 MALE PATIENTS WERE IDENTIFIED WITH AVAILABLE DIABETES AND BODY MASS INDEX (BMI). THE INCIDENCE OF ALL-CAUSE REINTERVENTION, MECHANICAL FAILURE, ATROPHY, AND EROSION OR INFECTION WAS ASSESSED. IN TOTAL, 90 (16%) MEN HAD DIABETES. ON MULTIVARIATE ANALYSIS, DIABETES WAS INDEPENDENTLY ASSOCIATED WITH AN INCREASED RISK OF EROSION/INFECTION (HAZARD RATIO [HR] 2.26; P=0.02), WHEREAS HIGH BMI WAS ASSOCIATED WITH REDUCED RISK OF EROSION/INFECTION (OBESE: HR 0.39; P=0.02; OVERWEIGHT: HR 0.57; P=0.07). IN DIABETIC PATIENTS, THE INCIDENCE OF EROSION/INFECTION WAS LOWER IN PATIENTS USING ANTIMICROBIAL-COATED DEVICES THAN IN PATIENTS USING NON-COATED DEVICES (1/28 CASE VS 13/62 CASE; P=0.035). THERE WAS NO DIFFERENCE IN SOCIAL CONTINENCE (</= 1 PAD/DAY) (45% VS 57%; P=0.29) OR HIGH-LEVEL SATISFACTION (95% VS 90%; P=0.43) AMONG DIABETICS VS NONDIABETICS. HOWEVER, WITH GREATER BMI (<25, 25 TO <30, AND >/= 30), THERE WAS A DECREASE IN </= 1 PAD/DAY USAGE (62% VS 61% VS 49%; P=0.02). THE PRESENCE OF DIABETES WAS INDEPENDENTLY ASSOCIATED WITH A 2.3-FOLD INCREASED RISK OF AUS EROSION OR INFECTION. MEDIAN FOLLOW-UP AMONG LIVING PATIENTS WITHOUT A DEVICE EVENT WAS 5.9 YEARS. IN TOTAL, 174 MEN REQUIRED AUS REINTERVENTION AT A MEDIAN 3.5 YEARS, INCLUDING 60 MECHANICAL FAILURES AT 4.4 YEARS, 52 EROSION OR INFECTIONS AT 1.8 YEARS, AND 49 ATROPHY EVENTS AT 4.5 YEARS. WHEN COMPARING THOSE WITH AND WITHOUT DIABETES, THERE WAS NO DIFFERENCE IN THE 5 YEAR CUMULATIVE INCIDENCE OF ALL-CAUSE AUS REINTERVENTION (27% VS 27%; P=0.90). MEANWHILE, MEN WITH DIABETES HAD A SIGNIFICANTLY GREATER 5 YEAR INCIDENCE OF EROSION OR INFECTION (13% VS 8%; P=0.25). THE IMPACT OF DIABETES MELLITUS AND OBESITY ON ARTIFICIAL URINARY SPHINCTER OUTCOMES IN MEN [UROLOGY 98: 176-182, 2016]. DOI: 10.1016/J.UROLOGY.2016.06.038.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988045 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R