BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAFUSER PUMP

    MDR report key: 23862820 · Received December 22, 2025

    Report

    Report Number
    MW5180865
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 16, 2025
    Manufacturer
    PHILLIPS-MEDISIZE A/S
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED: THE HCP IN AUSTRALIA REPORTED THE PATIENT'S VYALEV - VYAFUSER PUMP GOT TURNED OFF ON (B)(6) 2025 WITHOUT INTENTION. ON (B)(6), (B)(6) FOUND THE PUMP STOPPED WITHOUT INTENTION. HCP IS INQUIRING ON POSSIBLE INTERFERENCE WITH MDT DBS DEVICE. HCP NOTED THEY HAVE CONTACTED THE PUMP MANUFACTURER. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743437 VYAFUSER PUMP PUMP, INFUSION FRN PHILLIPS-MEDISIZE A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABBVIE - VYALEV.| MDT DBS DEVICE.