BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTLIGHT

    MDR report key: 19037051 · Received April 3, 2024

    Report

    Report Number
    1225698-2024-00006
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 3, 2024
    Manufacturer
    CARDIOFOCUS
    Product Code
    OAE
    UDI-DI
    00859373007433
    PMA / PMN Number
    P150026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE DEFICIENCY REPORTED. PHRENIC NERVE INJURY IS A KNOWN POTENTIAL ADVERSE EVENT FOR CATHETER ABLATION PROCEDURES DISCLOSED IN PRODUCT LABELING.

    Description of Event or Problem · 0

    DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, A PHRENIC NERVE INJURY WAS REPORTED DURING ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). CAPTURE OF THE PHRENIC NERVE COULD NOT BE ACHIEVED DURING THE REMAINDER OF THE PROCEDURE. CONFIRMATION THE PNI HAD RESOLVED WAS RECEIVED APPROXIMATELY 3 WEEKS POST-PROCEDURE. IT IS UNKNOWN WHEN THE PNI RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448420 HEARTLIGHT HEARTLIGHT X3 CATHETER OAE CARDIOFOCUS 18-5000 00859373007433

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other