BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANT X4 CRT-D

    MDR report key: 9947329 · Received April 9, 2020

    Report

    Report Number
    2124215-2020-06495
    Event Type
    Malfunction
    Date Received
    April 9, 2020
    Date of Event
    December 29, 2019
    Report Date
    April 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589287
    PMA / PMN Number
    P010012/S436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. INVESTIGATION OF THE AVAILABLE INFORMATION DETERMINED THIS DEVICE EXHIBITED OVERSENSING OF NOISE GENERATED BY THE MINUTE VENTILATION (MV)/RESPIRATORY SENSOR THAT IS RELATED TO A HIGH IMPEDANCE CONDITION. PLEASE SEE THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES DUE TO OVERSENSING OF THE MINUTE VENTILATION SENSOR. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) PACING IMPEDANCE MEASUREMENTS HAD DECREASED FROM 900 OHMS TO 600 OHMS. A FEW MONTHS LATER THE IMPEDANCE MEASUREMENTS WERE NOTED TO BE 800-900 OHMS. THE DEVICE WAS REPROGRAMMED TO MITIGATE THE INAPPROPRIATE EPISODES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409699 VIGILANT X4 CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G247 177635 00802526589287

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR