BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 2871401 · Received December 5, 2012

    Report

    Report Number
    2183959-2012-03098
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    September 19, 2012
    Report Date
    November 14, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP "WAS INSERTED IN AN UPSIDE DOWN POSITION" DUE TO A "PREVIOUS INJURY FROM 19 YEARS AGO THAT HAS INFLUENCED THE SURGICAL POSITIONING" AND THAT "SCAR TISSUE APPEARS TO BE INFLUENCING THE ACCESS TO THE PUMP AS WELL." IT WAS ALSO REPORTED THAT THE DEVICE "HAS NOT WORKED AT ALL" AND THAT THE PATIENT HAS "SORENESS AND DISCOMFORT." A "REVISION" WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2012. THE RESERVOIR AND CUFF WERE CHECKED AND THE PUMP WAS REPLACED IN THE "DOWN" POSITION. THE DEVICE WAS "FULLY OPERABLE AND FUNCTIONING WELL" AT THE END OF THE PROCEDURE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS SPHINCTER 800 URINARY PROSTHESIS ARTIFICIAL URINARY SPHINCTER FAG AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R