BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 24305911 · Received February 10, 2026

    Report

    Report Number
    2017865-2026-02148
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    January 21, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    OJX
    UDI-DI
    05414734502610
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION D10, THE CORRECT CONCOMITANT MEDICAL PRODUCTS IN 2017865-2026-02148 SHOULD HAVE BEEN UNIFY ASSURA, DURATA AND TENDRIL SDX, RATHER THAN UNIFY ASSURA, TENDRIL AND TENDRIL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH CAPTURE THRESHOLDS AND OUT OF RANGE IMPENDENCE WERE NOTED ON THE LEFT VENTRICULAR (LV) LEAD. THE CHRONIC LV LEAD WAS CAPPED ON (B)(6) 2026, AND A NEW LEAD WAS IMPLANTED. THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365951 QUICKFLEX MICRO LV LEAD DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1258T/86 3433455 05414734502610

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention DURATA.| TENDRIL SDX.| TENDRIL.| TENDRIL.| UNIFY ASSURA.| UNIFYASSURA.