BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSENTIO MRI DR

    MDR report key: 8717758 · Received June 20, 2019

    Report

    Report Number
    2124215-2019-10497
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    February 24, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526558962
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING FILED AS THE CONCLUSION CODE WAS UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PACEMAKER PATIENT EXPERIENCED SYNCOPAL EPISODES. THE DEVICE WAS INTERROGATED AND THE RIGHT VENTRICULAR (RV) LEAD WAS CAPTURING, HOWEVER, THE HOSPITAL MONITOR INDICATED THE PATIENT'S HEART RATE WAS 34 BEATS PER MINUTE (BPM). THE DEVICE ALSO DECLARED TWO FALSE POSITIVE SIGNAL ARTIFACT MONITOR (SAM) EPISODES DUE TO ATRIAL FIBRILLATION (AFIB). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE DATA IN THE REMOTE MONITORING SYSTEM AND INDICATED IN FEBRUARY THE RV LEAD IMPEDANCES SPIKED FROM 400 OHMS TO 1610 OHMS. TROUBLESHOOTING WAS PERFORMED AND VARIABLE IMPEDANCES AS WELL AS NOISE WERE REPRODUCED. TS WAS UNABLE TO DETERMINE IF IT WAS A SPRING CONTACT ISSUE IN THE DEVICE HEADER OR A LEAD ISSUE. TS RECOMMENDED IF A REVISION PROCEDURE WAS PERFORMED, TESTING THE LEAD ON THE PACING SYSTEM ANALYZER (PSA) TO RULE OUT A DEVICE ISSUE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE PHYSICIAN ELECTED TO NOT TEST THE RV LEAD ON THE PSA, AND WILL CONTINUE TO MONITOR THE PATIENT'S SYSTEM THROUGH THE REMOTE MONITORING SYSTEM. THIS PACEMAKER REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514202 ESSENTIO MRI DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L111 390612 00802526558962

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R