BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSENTIO MRI DR

    MDR report key: 15853535 · Received November 23, 2022

    Report

    Report Number
    2124215-2022-48783
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    November 10, 2022
    Report Date
    November 23, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE PACEMAKER WAS FEELING FATIGUE AND GENERALLY UNWELL WHILST WALKING AND THE TIMING OF THEIR SYMPTOMS CORRELATE TO PACEMAKER MEDIATED TACHYCARDIA (PMT) EPISODES STORED. IT WAS ALSO OBSERVED POTENTIAL FAILURE TO CAPTURE IN THESE EPISODES. FURTHER REVIEW BY TECHNICAL SERVICES (TS) WAS REQUESTED. UPON REVIEW OF THE DEVICE EPISODES BY TS IT WAS DISCUSSED THAT THERE ARE PMT EPISODES DUE TO THE ATRIAL RATE BEING BELOW THE PROGRAMMED ATRIAL TACHY RESPONSE (ATR) RATE. THE FAILURE TO CAPTURE OBSERVATION WAS ALSO CONFIRMED, WHICH WAS DISCUSSED TO BE LIKELY DUE TO THE SLIGHTLY VARIABLE NATURE OF THE THRESHOLD AND THE SAFETY MARGIN USED. IN ADDITION, IT WAS OBSERVED THAT THERE IS NO NOISE PRESENT IN THE STORED EPISODES. FURTHER RECOMMENDATIONS WERE PROVIDED BY TS. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239915 ESSENTIO MRI DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L111 521006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown