BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 17383334 · Received July 24, 2023

    Report

    Report Number
    2124215-2023-39057
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    July 2, 2023
    Report Date
    July 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6A. SURGERY OCCURRED SOMETIMES IN MARCH, ACTUAL IMPLANT DATE IS UNKNOWN. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOM IS A KNOWN RISK ASSOCIATED WITH IMPLANT OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) WAS SEEN BY A PHYSICIAN FOR ACTIVATION AND THE PHYSICIAN WAS UNABLE TO ACTIVATE THE DEVICE. THE PATIENT WAS INSTRUCTED TO ATTEMPT ACTIVATION HIMSELF AT HOME. THE PATIENT NOTED THAT HE WAS STILL SORE. ALSO, THE PATIENT STATED THAT THE PUMP FELT COMPLETELY FLAT. TROUBLESHOOTING GUIDANCE WAS PROVIDED AND IT WAS RECOMMENDED THAT THE PATIENT CONTACT THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369570 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other