BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 5557935 · Received April 7, 2016

    Report

    Report Number
    2649622-2016-04344
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 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), AND THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT. BEGINNING ON (B)(6) 2016, 91 VENTRICULAR SENSING INTEGRITY COUNTS (SIC); HIGH RATE-NS DETECTED EPISODES WITH LEAD NOISE OVERSENSING. RV LEAD INTEGRITY WARNING OCCURRED ON (B)(6) 2016 FOR 2 OR MORE HIGH RATE-NS EPISODES AND SENSING INTEGRITY COUNTER (SIC) GREATER THAN OR EQUAL TO 30 IN 3 DAYS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO OVERSENSING NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. 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
    210008 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R