BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 700 MS PUMP

    MDR report key: 24793846 · Received April 6, 2026

    Report

    Report Number
    2124215-2026-18645
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    February 24, 2026
    Report Date
    April 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    UDI-DI
    00878953003986
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED. THEREFORE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION. MODEL NUMBER/CATALOG NUMBER: 7240401, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 100038997, MODEL/CATALOG DESCRIPTION: CYLINDER, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404161, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1000527108, MODEL/CATALOG DESCRIPTION: RESERVOIR, UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL BECAUSE THE PRODUCT WAS NOT FUNCTIONING PROPERLY. TWO WEEKS LATER UPON INSPECTION, A CRACK WAS FOUND IN THE RIGHT CYLINDER CONNECTING TUBE, SO THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854583 AMS 700 MS PUMP PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 72404310 1000565236 00878953003986

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| H