BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS 800 ARTIFICIAL URINARY SPHINCTER

    MDR report key: 24463802 · Received February 26, 2026

    Report

    Report Number
    2124215-2026-10880
    Event Type
    Death
    Date Received
    February 26, 2026
    Date of Event
    October 13, 2025
    Report Date
    March 31, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4) AND FOR BALLON IS (B)(4).

    Additional Manufacturer Narrative · 0

    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 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. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE CARDIAC ARREST EVENT WAS DEFINED IN THE PRODUCT RISK DOCUMENTATION AS A GENERAL SURGICAL RISK. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF DEVICE PROBLEM EXCLUDED WAS ASSIGNED TO THIS INVESTIGATION. MODEL NUMBER/CATALOG NUMBER: 72400024. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100754521. MODEL/CATALOG DESCRIPTION: BALLOON . UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404127. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100727524. MODEL/CATALOG DESCRIPTION: PUMP. UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) DIED IN THE POSTOPERATIVE PERIOD. THE PATIENT EXPERIENCED CARDIAC ARREST IN THE RECOVERY AREA AND COULD NOT BE REVIVED. NO DEVICE ISSUES WERE REPORTED, AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) DIED IN THE POSTOPERATIVE PERIOD. THE PATIENT EXPERIENCED CARDIAC ARREST IN THE RECOVERY AREA AND COULD NOT BE REVIVED. NO DEVICE ISSUES WERE REPORTED, AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526492 AMS 800 ARTIFICIAL URINARY SPHINCTER DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404131 1100715856

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death BALLOON: UPN 72400024/ LOT 1100754521.| PUMP: UPN 72404127/ LOT 1100727524.