BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT INTRODUCER, UNKNOWN

    MDR report key: 21076612 · Received January 5, 2025

    Report

    Report Number
    3008452825-2025-00007
    Event Type
    Injury
    Date Received
    January 5, 2025
    Report Date
    February 26, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3, H6, H11. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF ARRHYTHMIA, IN AN ARTICLE TITLED "PREDICTORS OF LONG-TERM SUCCESS AFTER HIGH-DENSITY MAPPING-GUIDED SUBSTRATE ABLATION PROCEDURES FOR VENTRICULAR TACHYCARDIA IN PATIENTS WITH ISCHEMIC CARDIOMYOPATHY"; 2024;40:1442¿1451.BALT, J.C., DOI:10.1002/JOA3.13175 OBSERVATIONAL COHORT STUDY INCLUDES PATIENTS WITH ISCHEMIC HEART DISEASE WHO UNDERWENT HD MAPPING- GUIDED SUBSTRATE ABLATION OF VENTRICULAR TACHYCARDIA. BASELINE AND PROCEDURAL CHARACTERISTICS WERE ASSOCIATED WITH OUTCOMES AFTER VENTRICULAR TACHYCARDIA ABLATION. THE WAS ONE OCCURRENCE OF A VASCULAR COMPLICATION AND 2 CARDIAC TAMPONADES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136551 AGILIS NXT INTRODUCER, UNKNOWN INTRODUCER, CATHETER DYB ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TACTICATH CONTACT FORCE ABLATION CATHETER, SE