BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3992523 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09817
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 RIGHT VENTRICULAR (RV) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT. RV LEAD INTEGRITY WARNING OCCURRED (B)(4) 2014 FOR RV PACING IMPEDANCE GREATER THAN 3000 OHMS. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV PACING LEAD WAS RISING. ANALYST COMMENTED, ON (B)(4) 2014, RV BIPOLAR LEAD IMPEDANCE GRADUALLY RISING FROM 700 OHMS IN (B)(4) 2012 TO OVER 3000 OHMS. ON (B)(4) 2014, RV BIPOLAR LEAD IMPEDANCE MEASURED 3306 OHMS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OFFICE VISIT THAT A LEAD INTEGRITY ALERT WAS TRIGGERED AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE. IT WAS ALSO INDICATED THAT THE RV LEAD EXHIBITED SLOW BUT PERSISTENT INCREASED IMPEDANCE. NO ACTIONS WERE TAKEN, AND THE RV LEAD REMAINS IN USE. IT WAS RECOMMENDED THAT THE RV LEAD BE REPLACED OR CLOSELY MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468672 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR D294VRC ICD