BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3862449 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06867
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), THERE WAS A RIGHT VENTRICULAR LEAD INTEGRITY ALERT, THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE, THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS VARIABLE, AND THERE WAS OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. ON (B)(4) 2014 THERE WAS AN RV LEAD INTEGRITY WARNING FOR NON-SUSTAINED TACHYCARDIA (NST) EVENTS AND SHORT INTERVAL COUNTS (SIC). BEGINNING (B)(4) 2014 SIC COUNT IS 2087. BEGINNING (B)(4) 2014 RV PACING IMPEDANCE SPIKED TO 1026 OHMS. THE RV LEAD TREND IS VARYING FROM 874 OHMS TO 1026 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SHORT INTERVAL COUNTS (SIC) ON THE RIGHT VENTRICULAR (RV) LEAD AND EPISODES OF NOISE ON THE RV CHANNEL. DURING REVISION IT WAS NOTED THAT THE PACING LEAD IMPEDANCE WAS UNSTABLE AND HIGH WITH THE ANALYZER. THE 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
    337620 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R