BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4160413 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11926
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CONCOMITANT PRODUCTS: 4076 LEAD IMPLANTED: (B)(6) 2013; 4598 LEAD IMPLANTED: (B)(6) 2013. (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 RIGHT VENTRICULAR (RV) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ANALYST COMMENTED, MAXIMUM DEFIBRILLATOR ACTIVE CAN IMPEDANCE RISES FROM 73 OHM THE WEEK ENDING (B)(4) 2013 TO 119 OHM THE WEEK ENDING (B)(4) 2014. ANALYSIS OF THE DEVICE MEMORY INDICATED A LEAD IMPEDANCE OUT OF RANGE ALERT. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE DEFIBRILLATION COIL WAS RISING. ANALYST COMMENTED, AN OUT OF THRESHOLD SUBTHRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON (B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUAL INCREMENT OF IMPEDANCE. THE RV LEAD REMAINS IN USE. PROGRAM ADJUSTMENTS OF THE RV LEAD WERE RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638527 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR DTBC2QQ ICD