BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 ARTIFICIAL URINARY SPHINCTER

    MDR report key: 23887760 · Received December 24, 2025

    Report

    Report Number
    2124215-2025-92894
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    June 14, 2014
    Report Date
    January 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953000626
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT UDI FOR CUFF IS (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOM OF INCONTINENCE IS A KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT UDI FOR CUFF IS (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. THE REPORTED PATIENT SYMPTOM OF INCONTINENCE IS A KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. BASED ON THE INFORMATION AVAILABLE, A CLEAR PROBABLE CAUSE FOR THE EVENT CANNOT BE ESTABLISHED; THEREFORE, THE CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM HAS BEEN CHOSEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED A SUDDEN RETURN OF INCONTINENCE, AND IMAGING REVEALED A DEFLATED PRESSURE BALLOON. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE CUFF, AND BALLOON WERE REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED A SUDDEN RETURN OF INCONTINENCE, AND IMAGING REVEALED A DEFLATED PRESSURE BALLOON. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE CUFF, AND BALLOON WERE REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299553 AMS 800 ARTIFICIAL URINARY SPHINCTER DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72400024 885142015 00878953000626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H LOT: 862246008 UPN: 72400160.| LOT: 862246008 UPN: 72400160.