BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALFAPUMP SYSTEM

    MDR report key: 23627671 · Received November 23, 2025

    Report

    Report Number
    3010817031-2025-00003
    Event Type
    Injury
    Date Received
    November 23, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 23, 2025
    Manufacturer
    SEQUANA MEDICAL
    Product Code
    SDQ
    PMA / PMN Number
    P230044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    OUTSIDE US BECAUSE IN CANADA: PATIENT WAS INITIALLY IMPLANTED WITH PUMP SN (B)(6) UNDER THE POSEIDON STUDY ((B)(6)) ON (B)(6) 2022. THE PUMP HAS BECOME NON-FUNCTIONAL ON (B)(6) 2024. THE ALFAPUMP SN (B)(6) REACHED IT`S END OF LIFE AFTER ~714 DAYS. DUE TO THE AVAILABILITY OF A NEW PUMP, THE RE-INTERVENTION AND REPLACEMENT HAS BEEN DELAYED TO (B)(6) 2025. THE REPLACEMENT PUMP SN (B)(6) HAS BEEN APPROVED UNDER THE SPECIAL ACCESS PROGRAM AND REQUEST NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490511 ALFAPUMP SYSTEM ALFAPUMP SYSTEM SDQ SEQUANA MEDICAL ALFAPUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization