BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3990011 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08875
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. (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 ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE, LEAD IMPEDANCE OUT OF RANGE ALERT, AND OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). AN OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON (B)(6) 2014. MAX VENTRICULAR PACE IMPEDANCE RISES FROM 779 OHM ON (B)(6) 2014 TO GREATER THAN 4000 OHM ON (B)(6) 2014. THERE IS ONE LEAD FAILURE PREDICTOR (LFP) EVENT OF LESS THAN 220 MS V-V CYCLE RECORDED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT A NEW PACE/SENSE LEAD WAS IMPLANTED AND THE HIGH VOLTAGE PORTION OF LEAD REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT WAS TRIGGERED FOR HIGH IMPEDANCE ON THE RV PACE/SENSE. THE RV THRESHOLD HAS ALSO RISEN WITH NOISE IN THE VENTRICULAR FIBRILLATION (VF) ZONE. IT WAS NOTED THERE WAS POSSIBLE FRACTURE. THE LEAD 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
    462519 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1