BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 7354982 · Received March 20, 2018

    Report

    Report Number
    2124215-2018-04758
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 12, 2018
    Report Date
    February 12, 2018
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    LWP
    UDI-DI
    00802526524516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS BEING CHECKED, AS THE PATIENT HEARD BEEPING. THE BEEPING WAS IN RESPONSE TO THIS LEFT VENTRICULAR (LV) LEAD PACE IMPEDANCE, THAT WAS RECORDED OUT OF RANGE. AT THE IMPLANT A FEW MONTHS AGO, THE PACE IMPEDANCE MEASURED AT APPROXIMATELY 3000 OHMS AND SEEMS TO BE TRENDING NOW AROUND 200-1300 OHMS. THE IMPEDANCE TREND THAT TRIGGERED THE ALERT WAS GREATER THAN 2000 OHMS. DURING THE CRT-D CHECK, LEAD TESTING REVEALED ALL CONFIGURATIONS WERE AROUND THE 1500 OHM RANGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THIS DOES NOT APPEAR TO BE A LEAD ISSUE. THE FIELD REPRESENTATIVE WAS GOING TO PROGRAM THE OUT OF RANGE LIMIT HIGHER AND WAS GOING TO REGISTER THE PATIENT TO CONTINUE TO MONITOR THE SITUATION VIA THE REMOTE MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197751 ACUITY IMPLANTABLE LEAD LWP CPI PLANT - ST. PAUL 4671 00802526524516

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR 0295| 4671| 7740| G148