BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

    MDR report key: 8152666 · Received December 11, 2018

    Report

    Report Number
    2183959-2018-61548
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 21, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953003092
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER: BALLOON: 72400024, PUMP: 72404127. (B)(4). CATALOG NUMBER: BALLOON: 72400024, PUMP: 72404127. (B)(4). EXPIRATION DATE: BALLOON: 05/01/2017, PUMP: 01/31/2013. MANUFACTURE DATE: BALLOON: 05/14/2012, PUMP: 02/14/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE DUE TO URETHRAL ATROPHY WITH THEIR ARTIFICIAL URINARY SPHINCTER CUFF. THE PATIENT'S INCONTINENCE WAS STILL BETTER THAN BASELINE. THE SYSTEM WAS REPLACED A FEW MONTHS LATER WITH A 4.5 CM CUFF, PUMP AND 61-70 CMH2O BALLOON. THE PATIENT HAD NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991432 AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404131 683427005 00878953003092

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R