BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 23203218 · Received October 2, 2025

    Report

    Report Number
    2017865-2025-1001829
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 15, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF LOOSE OR INTERMITTENT CONNECTION WAS CONFIRMED. THE DEVICE VOLTAGE WAS ABOVE ELECTIVE REPLACEMENT INDICATOR (ERI) UPON RECEIPT. ASSESSMENT OF TOTAL PROJECTED LONGEVITY WAS PERFORMED, AND THE DEVICE WAS FOUND TO HAVE APPROPRIATE REMAINING LONGEVITY. ANALYSIS REVEALED THE RIGHT VENTRICULAR SET SCREWS CONTAINED SEPTUM MATERIAL INSIDE THEIR HEX CAVITIES. THIS MATERIAL IN THE HEX CAVITY PREVENTED FULL INSERTION OF THE TORQUE DRIVER AND WAS THE CAUSE OF THE REPORTED EVENT. THE SET SCREW ANOMALY WAS CONSISTENT WITH HAVING OCCURRED DURING THE PROCEDURE. ELECTRICAL AND MECHANICAL TESTS PERFORMED INCLUDING LEAD IMPEDANCE AND OUTPUT VERIFICATION DID NOT IDENTIFY ANY FUNCTIONAL ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT PROCEDURE. DURING THE PROCEDURE, THE HEW WRENCH DID NOT FIT IN THE SET SCREW PROPERLY. THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT USED, AND THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE USING A DIFFERENT ICD. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434310 QUADRA ASSURA MP ICD NO MATCH NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3371-40C A000169467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown