BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY MRI

    MDR report key: 20510035 · Received October 22, 2024

    Report

    Report Number
    2124215-2024-66239
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    July 16, 2024
    Report Date
    October 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALERT HAD BEEN GENERATE FOR CARDIAC RESYNCHRONIZATION THERAPY PACING OF LESS THAN 90 PERCENT FOR APPROXIMATELY ONE DAY. ADDITIONALLY, ATRIAL PACING IMPEDANCE HAS BEEN VARIABLE WITH A CHANGE OF GREATER THAN 30 PERCENT. MEASUREMENTS HAVE VARIED BETWEEN 600-1190 OHMS. THE MOST RECENT MEASUREMENT WAS STABLE AT 600 OHMS. ADDITIONAL INFORMATION WAS RECEIVED THAT AN ALERT WAS GENERATED FOR AN OUT-OF-RANGE ATRIAL PACING IMPEDANCE MEASUREMENT GREATER THAN 3000 OHMS. ADDITIONALLY, THERE WAS A SIGNAL ARTIFACT MONITORING (SAM) EPISODE WHICH SHOWED MINUTE VENTILATION (MV) VECTOR SWITCH DUE TO POSSIBLE ELECTRICAL NOISE THAT WAS OVERSENSED ON THE ATRIAL CHANNEL. THE CLINICAL OBSERVATIONS WERE DOCUMENTED. THIS SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566696 INGEVITY MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7736 627957

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown