BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3992545 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09823
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    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 OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS SENSING INTEGRITY COUNTER (SIC). ANALYST COMMENTED, BEGINNING 30 APRIL 2014, SENSING INTEGRITY COUNTS BEGAN INCREASING TO 2888 WITH NON SUSTAINED EVENTS AND VENTRICULAR FIBRILLATION (VF) EPISODES DETECTED WITH INAPPROPRIATE SHOCKS. ANALYSIS OF THE DEVICE MEMORY INDICATED THE RIGHT VENTRICULAR LEAD (RV) INTEGRITY ALERT. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ON WEEK OF 13 MAY 2014, RV BIPOLAR LEAD IMPEDANCE SPIKED FROM 741 OHMS TO 4047 OHMS. RV LEAD INTEGRITY WARNING OCCURRED 30 APRIL 2014 FOR SENSING INTEGRITY COUNTER GREATER THAN 30 IN 3 DAYS AND HIGH RATE NON SUSTAINED EPISODES.

    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 THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED FRACTURE. THE RV LEAD EXHIBITED HIGH IMPEDANCE, HIGH THRESHOLD, SHORT V-V INTERVALS, AND NOISE WAS ENCOUNTERED WITH ISOMETRIC MOVEMENT. IT WAS ALSO NOTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467676 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-75

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Congenital Anomaly| H| R D294DRG ICD