BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLAMAP ORION?

    MDR report key: 25150993 · Received May 12, 2026

    Report

    Report Number
    2124215-2026-25590
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRF
    UDI-DI
    08714729841968
    PMA / PMN Number
    K143481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G4: K192360, K220796. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS CONTAMINATED PRIOR TO THE PROCEDURE. PRIOR TO THE PROCEDURE, AN INTELLAMAP ORION CATHETER WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE CATHETER WAS CONTAMINATED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242526 INTELLAMAP ORION? CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC CORPORATION M004RC64S0 0036740578 08714729841968

    Patients

    Seq Age Sex Outcome Treatment
    1