BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE MRI DR

    MDR report key: 17139159 · Received June 15, 2023

    Report

    Report Number
    2124215-2023-31001
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 26, 2023
    Report Date
    June 15, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED ATRIAL UNDERSENSING. F-WAVE UNDERSENSE AND PREMATURE VENTRICULAR CONTRACTION (PVC) MARKER WERE NOTED AND SUSPECTED IT AS PVC NOTATION AS THE FIELD REPRESENTATIVE COULD NOT SEE THE F-WAVE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT WHEN ATRIAL UNDERSENSING OCCURS IN DDD, THE MARKER OF VENTRICULAR SENSING IS PVC. THE PVC MARKERS ONLY INDICATES THAT THERE WAS NO PRECEDING ATRIAL EVENT. THE FINAL DEVICE SETTING WAS VVI WHICH INDICATES THAT THE ATRIAL SENSING WAS TURNED OFF. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815474 ACCOLADE MRI DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L311 335616

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female