BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3862204 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06998
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    June 1, 2013
    Report Date
    April 3, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS DECREASING AND IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING. RV PACING IMPEDANCE SINCE WEEK OF (B)(6) 2014 JUMPED FROM 888 OHMS TO 1024 OHMS UP TO THE HIGHEST OF 1952 OHMS THE WEEK OF (B)(6) 2014. RV PACING IMPEDANCE TREND HAS FALLEN FROM A HIGH OF 872 OHMS ON (B)(6) 2013 TO A LOW OF 752 OHMS ON THE WEEK OF (B)(6) 2013. RV PACING IMPEDANCE TREND IS SLOWLY RISING EACH WEEK APPROXIMATELY 30-40 OHMS.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INITIAL DECREASE IN THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE WHICH RETURNED TO THE BASELINE VALUES AND THEN APPROXIMATELY SIX MONTHS LATER THE PACING IMPEDANCE BEGAN TO GRADUALLY INCREASE AND ARE NOW HIGH BUT STABLE. THE RV THRESHOLDS AND SENSING WERE REPORTED TO BE STABLE. THE LEAD WILL CONTINUE TO BE MONITORED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342132 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 7232 ICD