BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSENTIO MRI DR

    MDR report key: 19137792 · Received April 18, 2024

    Report

    Report Number
    2124215-2024-23702
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    April 2, 2024
    Report Date
    April 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526558962
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED FARFIELD OVERSENSING OF VENTRICULAR SIGNALS ON THE ATRIAL CHANNEL IN THE STORED ATRIAL TACHY RESPONSE (ATR) EPISODES. ADDITIONALLY, THERE WAS UNDERSENSING OF THE ATRIAL SIGNALS ON THE PRESENTING THAT RESULTED IN FUNCTIONAL LOSS OF CAPTURE (LOC) OF AN ATRIAL PACE. TECHNICAL SERVICES (TS) SUGGESTED REPROGRAMMING FOR OPTIMIZATION. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254305 ESSENTIO MRI DR IMPLANTABLE PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION L111 546626 00802526558962

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female