BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

    MDR report key: 24221364 · Received January 30, 2026

    Report

    Report Number
    2017865-2026-02034
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 16, 2026
    Report Date
    March 17, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    PNJ
    UDI-DI
    05415067040725
    PMA / PMN Number
    P150035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES. THE REPORTED EVENTS OF INTERMITTENT CAPTURE, DEVICE DISLODGED OR DISLOCATED, AND FAILURE TO CONNECT WERE NOT CONFIRMED. VISUAL INSPECTION NOTICED THE HELIX WAS STRETCHED OUT OF SPECIFICATION. THE HELIX ELONGATION IS CONSISTENT WITH HAVING OCCURRED DURING THE IMPLANT PROCEDURE CAUSED BY THE END-USER. ADDITIONAL INSPECTION OF THE DEVICE DOCKING BUTTON DIAMETER WAS FOUND TO BE WITHIN SPECIFICATION. ELECTRICAL AND MECHANICAL ANALYSIS PERFORMED INDICATED NORMAL FUNCTIONALITY. FURTHER EVALUATION OF THE OUTPUT SIGNAL CONFIRMED ALL PACING PARAMETERS WERE WITHIN NORMAL RANGE. REVIEW OF DEVICE HISTORY RECORD (DHR) INDICATES THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE DEVICE PASSED ALL TESTS PRIOR TO ITS DISTRIBUTION. LONGEVITY ASSESSMENT WAS PERFORMED, AND DEVICE WAS IN NORMAL RANGE OF OPERATION WITH APPROPRIATE REMAINING LONGEVITY.

    Description of Event or Problem · 0

    DURING AN IMPLANT OF A VENTRICULAR LEADLESS PACEMAKER (VLP) ON (B)(6) 2026, IT WAS REPORTED THAT THERE WAS INTERMITTENT CAPTURE POST FIXATION ON THE VLP. FLUOROSCOPY REVEALED THE VLP WAS ROTATING APPROXIMATELY NINETY DEGREES WITH EACH HEARTBEAT INDICATING A POSSIBLE MICRO-DISLODGEMENT. THE VLP DISLODGED ENTIRELY AND EMBOLIZED TO THE RIGHT VENTRICLE UPON AN ATTEMPT TO RETRIEVE THE DEVICE AND REPOSITION IT. A SECOND ATTEMPT WAS MADE TO RETRIEVE THE VLP, BUT THE PHYSICIAN EXPERIENCED DIFFICULTIES WITH THE CONNECTION MECHANISM AND THE VLP EMBOLIZED FURTHER INTO THE CORONARY SINUS (CS). A THIRD UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE VLP IN THE CS. THE PHYSICIAN THEN USED AN ELECTROPHYSIOLOGY (EP) CATHETER AND CS SHEATH WHICH PROVED SUCCESSFUL IN RETRIEVING THE VLP. THE VLP WAS NOT USED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280998 AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSP202V S000108580 05415067040725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male