BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

    MDR report key: 15194050 · Received August 9, 2022

    Report

    Report Number
    2017865-2022-17166
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    July 20, 2022
    Report Date
    September 15, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    PNJ
    UDI-DI
    05415067034472
    PMA / PMN Number
    P150035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENTS OF SEPARATION FAILURE, DEVICE SENSING PROBLEM, LOW IMPEDANCE AND POSITIONING FAILURE COULD NOT BE CONFIRMED. FINAL ANALYSIS FOUND THAT VISUAL INSPECTION SHOWED THAT THE BUTTON HOLE DIAMETER WAS WITHIN SPECIFICATION AND ELECTRICAL AND MECHANICAL ANALYSIS PERFORMED INDICATED NORMAL DEVICE FUNCTIONALITY. LONGEVITY ASSESSMENT WAS PERFORMED, AND DEVICE WAS IN THE NORMAL RANGE OF OPERATION WITH APPROPRIATE REMAINING LONGEVITY. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION - D2 - DEVICE PRODUCT CODE SHOULD BE PNJ RATHER THAN LWO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A DEVICE IMPLANT PROCEDURE. UPON POSITIONING, IT WAS NOTED THAT THE VENTRICULAR LEADLESS PACEMAKER EXHIBITED LOW R-WAVES, LOW PACING IMPEDANCE AND WAS NOT PROPERLY FIXED. THE PHYSICIAN DECIDED TO REPOSITION. ONCE A SATISFACTORY LOCATION WAS FOUND, THE PHYSICIAN WAS UNABLE TO RELEASE THE DEVICE FROM THE CATHETER. THE DEVICE AND CATHETER WERE REMOVED AND STILL COULD NOT BE SEPARATED AFTER REMOVAL. A NEW DEVICE WAS IMPLANTED SUCCESSFULLY THROUGH USE OF A NEW CATHETER. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817596 AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSP112V S000086081 05415067034472
    302291 AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSP112V S000086081 05415067034472

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male LSCD111