BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 5557627 · Received April 7, 2016

    Report

    Report Number
    2649622-2016-04465
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    January 22, 2016
    Report Date
    January 22, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. 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), AND THE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYST COMMENTED, BEGINNING (B)(6) 2016, 56 VENTRICULAR SIC; HIGH RATE-NON SUSTAINED EPISODE WITH EVIDENCE OF LEAD NOISE OVERSENSING. ON (B)(6) 2016, RV PACING IMPEDANCE MEASURED GREATER THAN 3000 OHMS IN A TREND RISING FROM 500-600 OHMS, BEGINNING (B)(6) 2015. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE, HIGH THRESHOLDS AND NOISE. THE RV LEAD WAS ABANDONED AND REPLACED, AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211069 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R