BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

    MDR report key: 8067295 · Received November 13, 2018

    Report

    Report Number
    2183959-2018-60928
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 16, 2018
    Report Date
    January 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953005652
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IMPLANT DATE, LOT NUMBER CORRECTION. ADDITIONAL PRODUCT COMPONENT: MODEL NUMBER/CATALOG NUMBER 72404127 AND 7240024. SERIAL NUMBER: NULL AND NULL. BATCH/LOT NUMBER 683442009 AND 684642005. MODEL/CATALOG DESCRIPTION CONTROL PUMP FGS IZ AND BALLOON FGS 61-70 CM. THIS SUPPLEMENTAL CORRECTION REPORT IS BEING FILED TO CORRECT THE REPORT NUMBER IN A PREVIOUSLY SUBMITTED SUPPLEMENTAL REPORT (FOLLOW-UP NUMBER 001) WHICH WAS ACCEPTED BY FDA ON 12/14/2018 11:42 AM CT. THE REPORT NUMBER IS BEING CORRECTED FROM: 2183959-2018-61626 TO: 2183959-2018-60928.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE DUE TO URETHRAL ATROPHY WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF, PUMP, AND BALLOON WAS EXPLANTED AND NO NEW DEVICE WAS IMPLANTED. DURING EXPLANT THE PHYSICIAN OBSERVED A HOLE IN THE URETHRA, THE CAUSE OF THE HOLE WAS UNKNOWN IF IT WAS FROM THE SURGICAL PROCEDURE OR CUFF EROSION. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT COMPONENT: MODEL NUMBER/CATALOG NUMBER; 72404127 AND 7240024, SERIAL NUMBER: NULL AND NULL, BATCH/LOT NUMBER: 683442009 AND 684642005, MODEL/CATALOG DESCRIPTION: CONTROL PUMP FGS IZ AND BALLOON FGS 61-70 CM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF, PUMP, AND BALLOON WAS EXPLANTED AND NO NEW DEVICE WAS IMPLANTED. DURING EXPLANT THE PHYSICIAN OBSERVED A HOLE IN THE URETHRA, THE CAUSE OF THE HOLE WAS UNKNOWN IF IT WAS FROM THE SURGICAL PROCEDURE OR CUFF EROSION. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907596 AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404130 674816014 00878953005652

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R