BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 700 CX MS PUMP

    MDR report key: 21699425 · Received March 26, 2025

    Report

    Report Number
    2124215-2025-18068
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    March 11, 2025
    Report Date
    May 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    UDI-DI
    00878953003504
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THIS INFLATABLE PENILE PROSTHESIS AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY ANALYZED. MICROSCOPIC ANALYSIS IDENTIFIED BOTH CYLINDERS HAD WEAR AT FOLD IN THE PROXIMAL END, MIDDLE, AND DISTAL END OF THE CYLINDER AND, NO DAMAGE OR ABNORMALITIES WERE FOUND ON PUMP. THE DEVICE WAS TESTED TOO, CONCLUDING PUMP AND BOTH CYLINDERS PASSED LEAKAGE TEST; THE PUMP PASSED THE FUNCTIONAL TEST TOO. THE RESERVOIR WAS ALSO ANALYZED, IDENTIFYING IT HAD WEAR AT A FOLD IN RESERVOIR SHELL AND PASSING THE LEAKAGE TEST. THE ALLEGATION OF AIR IN THE SYSTEM/COMPONENT WAS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED, CAUSE NOT ESTABLISHED WAS SELECTED AS THE MOST PROBABLE CAUSE FOR THE COMPLAINT. CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). CONCOMITANT PRODUCT UDI FOR LGX PRECONNECT IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP HAS AIR POCKET AND DOES NOT WORK. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP HAS AIR POCKET AND DOES NOT WORK. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716185 AMS 700 CX MS PUMP PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 72404237 1100195243 00878953003504

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization| R LGX PRECONNECT: LOT: 1100494478, UPN: 72404252-10.| RESERVOIR: LOT: 110028199.| RESERVOIR: LOT: 1100482011, UPN: 720185-01.