BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 8122992 · Received December 1, 2018

    Report

    Report Number
    2183959-2018-61313
    Event Type
    Injury
    Date Received
    December 1, 2018
    Date of Event
    November 8, 2018
    Report Date
    January 7, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953000732
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER: BALLOON: 72400024; PUMP: 72400098; SERIAL NUMBER: BALLOON: 486700014; PUMP: 485534007; CATALOG NUMBER: BALLOON: 72400024; PUMP: 72400098; UDI NUMBER: BALLOON: 00878953000626; PUMP: 00878953000688; EXPIRATION DATE: BALLOON: 03/19/2012; PUMP: 03/08/2012; MANUFACTURE DATE: BALLOON: 03/27/2007 PUMP:03/20/2007;

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S EXPERIENCED RECURRING INCONTINENCE WITH THEIR ARTIFICIAL URINARY SPHINCTER. THE PATIENT HAD URETHRAL ATROPHY DUE TO THE CUFF. A COUPLE OF MONTHS LATER, THE DEVICE WAS REPLACED. THE PATIENT WAS DOING WELL AFTER THE REPLACEMENT.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER: BALLOON: 72400024; PUMP: 72400098; SERIAL NUMBER: BALLOON: (B)(4); PUMP: (B)(4); CATALOG NUMBER: BALLOON: 72400024; PUMP: 72400098; (B)(4); EXPIRATION DATE: BALLOON: 03/19/2012; PUMP: 03/08/2012; MANUFACTURE DATE: BALLOON: 03/27/2007; PUMP:03/20/2007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE AND ATROPHY WITH THEIR ARTIFICIAL URINARY SPHINCTER. THE DEVICE WAS REPLACED. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961885 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72400162 492500017 00878953000732

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R