BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY MRI

    MDR report key: 14131895 · Received April 16, 2022

    Report

    Report Number
    2124215-2022-11579
    Event Type
    Malfunction
    Date Received
    April 16, 2022
    Date of Event
    December 24, 2021
    Report Date
    April 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526523458
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    117

    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 RIGHT ATRIAL (RA) LEAD TRIGGERED A SIGNAL ARTIFACT MONITORING (SAM) EVENT DUE TO HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS SINCE (B)(6) 2021. IN ADDITION, NOISE WAS REPRODUCIBLE WITH ISOMETRICS; RA LEAD FRACTURE WAS SUSPECTED DUE TO IMPEDANCE MEASUREMENTS, SENSING, AND THRESHOLDS. IT WAS ALSO NOTED THAT THE PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION (AF) FOR THE PAST YEAR. TECHNICAL SERVICES (TS) RECOMMENDED TURNING OFF ATRIAL DISCRIMINATORS, CONSIDERING VVIR WITH A LOWER RATE LIMIT (LRL) OF 70 (CONSISTENT WITH ATRIAL TACHY RESPONSE LRL), TURNING OFF THE RA LEAD, AND TURNING OFF RA DAILY MEASUREMENTS (DM). THIS RA LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174688 INGEVITY MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7741 752544 00802526523458

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male