BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4161827 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11380
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    February 1, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING AND WAS BEYOND THE EXPECTED UPPER RANGE. NO SAVE TO DISK DATA WAS AVAILABLE ON CAPTURE THRESHOLDS RISING. ON (B)(6) 2014, RV TIP BIPOLAR IMPEDANCE MEASURED 1024 OHMS. ON (B)(6) 2014, RV BIPOLAR IMPEDANCE MEASURED 1808 OHMS. IMPEDANCE HAS BEEN STEADILY RISING FROM A LOW OF 340 OHMS ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGHER THAN NORMAL AND STEADILY INCREASING THRESHOLDS AND IMPEDANCES OVER THE PAST 6-8 MONTHS. THE LEAD REMAINS IN USE AND WILL CONTINUE TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640338 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR D154VWC ICD