BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

    MDR report key: 14854194 · Received June 29, 2022

    Report

    Report Number
    2017865-2022-13612
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 14, 2022
    Report Date
    August 11, 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
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF DEVICE DISLODGEMENT WAS NOT CONFIRMED. FINAL ANALYSIS FOUND THE HELIX WAS STRETCHED OUT OF SPECIFICATION. THE HELIX ELONGATION IS CONSISTENT WITH HAVING OCCURRED DURING PROCEDURE. FURTHER ANALYSIS WAS PERFORMED, AND THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS WITHOUT ANY ANOMALIES. LONGEVITY ASSESSMENT WAS PERFORMED, AND DEVICE WAS IN THE NORMAL RANGE OF OPERATION WITH APPROPRIATE REMAINING LONGEVITY.

    Additional Manufacturer Narrative · 0

    CORRECTION - D1 - DEVICE PRODUCT CODE SHOULD HAVE BEEN PNJ RATHER THAN LWO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEADLESS PACEMAKER IMPLANT PROCEDURE. DURING THE PROCEDURE, THE RIGHT VENTRICULAR LEADLESS PACEMAKER DISLODGED WHILE ATTEMPTING TO RELEASE THE DEVICE FROM THE CATHETER. THE SUSPECTED CAUSE WAS DUE TO IMPLANT TECHNIQUE/USER ERROR. THE DEVICE WAS THEN RELEASED OFF THE CATHETER AND PUSHED INTO THE PULMONARY ARTERY. THE DEVICE WAS RETRIEVED SUCCESSFULLY AND A NEW DEVICE WAS IMPLANTED IN A DIFFERENT LOCATION. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915683 AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSP112V S000086107 05415067034472
    2379223 AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSP112V S000086107 05415067034472

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male