BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 9186439 · Received October 14, 2019

    Report

    Report Number
    2183959-2019-66811
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    January 1, 2010
    Report Date
    October 14, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    IT WAS REPORTED THAT A MULTICENTER RETROSPECTIVE COHORT STUDY WAS PERFORMED TARGETING 47 PATIENTS (5 DIABETIC PATIENTS) PLACED WITH AMS800 ARTIFICIAL URINARY SPHINCTER (AUS) COATED WITH RIFAMPICIN + MINOCYCLINE (INHIBIZONE - IZ), AND 258 PATIENTS (47 DIABETIC PATIENTS) PLACED WITH UNCOATED (NON-IZ) AMS800 AUS. THE EFFECTS OF ANTIBACTERIAL COATING ON DEVICE INFECTION RATE AND REMOVAL RATED WERE EVALUATED. THE INFECTION RATE ON COATED GROUP AND UNCOATED GROUP WAS 8.5% AND 8.1% RESPECTIVELY. IN THE UNIVARIATE ANALYSIS, THERE WAS NO SIGNIFICANT DIFFERENCE ON THE INFECTION RATE (P=0.932) AND REMOVAL RATE (P=0.715) BETWEEN THE TWO GROUPS. AS FOR THE RESULT OF THE MULTIVARIATE ANALYSIS, IMPAIRED WOUND HEALING (P = 0.008) AND URETHRAL EROSION (P <0.001) WERE THE INDEPENDENT PREDICTORS OF INFECTION. THE ANTIMICROBIAL COATING DID NOT SIGNIFICANTLY AFFECT THE INFECTION RATE (P = 0.534) AND REMOVAL RATE (P = 0.214). THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS IN THE PERIOD OF NO INFECTION PLACEMENT (P=0.265). THE REMAINING COMPLICATIONS RATES WERE NOTED: POSTOPERATIVE BLEEDING - 0 IZ, 18 NON-IZ (P=0.062); IMPAIRED WOUND HEALING - 0 IZ, 7 NON-IZ (P=0.253); ACUTE URINARY RETENTION - 5 IZ, 30 NON-IZ (P=0.845); DISLOCATION OF IMPLANT - 0 IZ, 9 NON-IZ (P=0.194); URETHRAL EROSION - 4 IZ, 32 NON-IZ (P=0.447); INFECTION OF DEICE - 4 IZ, 21 NON-IZ (P=0.932); URETHRAL EROSION AND INFECTION - 5 IZ, 44 NON-IZ (P=-0.271); MECHANICAL FAILURE - 3 IZ, 6 NON-IZ (P=0.131); EXPLANTATION (NO CAUSE SPECIFIED) - 10 IZ, 49 NON-IZ (P=0.715). IT WAS NOT POSSIBLE TO OBTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS COMPLAINT WILL ADDRESS ALL ADVERSE EVENTS COVERED WITHIN THIS LITERATURE SOURCE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. ANTIBIOTIC COATING OF THE ARTIFICIAL URINARY SPHINCTER (AMS 800): IS IT WORTHWHILE?. [UROLOGY 103: 179-184, 2017]. DOI: HTTPS://DOI.ORG/10.1016/J.UROLOGY.2016.12.056. PMID: 28093308. THIS RECORD IS FOR THE NON-INHIBIZONE (NON-IZ) COATED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979026 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