BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 5858456 · Received August 9, 2016

    Report

    Report Number
    2649622-2016-08382
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 17, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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). ON (B)(4) 2016, 88 VENTRICULAR SIC EPISODES WERE RECORDED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE WAS STEADY AT APPROXIMATELY 414 OHMS THROUGH (B)(4) 2016, THEN INCREASED TO 722 OHMS BY (B)(4) 2016. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. THE LEAD FAILURE PREDICTOR ALERT WAS TRIGGERED ON (B)(4) 2016 DUE TO THE LEAD IMPEDANCE AND VENTRICULAR SIC. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THAT FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO AN ELEVATED SENSING INTEGRITY COUNTER (SIC) AND RISING AND VARYING RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE. THE PATIENT WAS SEEN BY THEIR PHYSICIAN AND WILL CONTINUE TO BE MONITORED. THE LEAD REMAINS ACTIVE AND 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
    513531 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR