BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4160985 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11688
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY #THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). IMPEDANCE TREND IS STABLE AND WITHIN NORMAL LIMITS. LEAD INTEGRITY ALERT (LIA) TRIGGERED (B)(6) 2014 FOR NON-SUSTAINED TACHYCARDIA (NST) AND SICC. 5 NST EPISODES WITH V-V INTERVALS <(><<)>= 220 MS BETWEEN (B)(6) 2014. CONCOMITANT PRODUCT: 419478 LEAD, IMPLANTED (B)(6) 2008; 407652 LEAD, IMPLANTED (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO ELEVATED SHORT INTERVAL COUNTS (SIC) ON THE RIGHT VENTRICULAR (RV) LEAD. 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
    642488 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR D314TRG ICD