BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153375 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05984
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. INTERFERENCE/NOISE OCCURRED, WITH A VENTRICULAR SHORT INTERVAL COUNT V-SIC OF 1189 COUNTS, IN 94.65 DAYS OCCURRING BETWEEN (B)(6) 2012. VARYING RESISTANCE/IMPEDANCE WAS NOTED, WITH WEEKLY PACE LEAD TREND DATA SHOWING VARYING IMPEDANCE FOR MIN AND MAX RIGHT VENTRICULAR (RV) PACE IMPEDANCE OF 392 TO 1120 OHMS PEAK BETWEEN (B)(6) 2011 AND (B)(6) 2013. OVERSENSING OCCURRED, WITH FIVE VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES OF LESS THAN OR EQUAL TO 210 MILLISECONDS BETWEEN (B)(6) 2012. THE LEAD INTEGRITY ALERT TRIGGERED. PROGRAMMER DATA SHOWS ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012. A PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHORT INTERVAL COUNTS (SIC) HAD INCREASED ON THE RIGHT VENTRICULAR LEAD AND AN ALERT TRIGGERED. THE ALARM WAS TURNED OFF. EIGHT MONTHS LATER DURING A DEVICE CHECK IT WAS NOTED THAT THERE WERE IMPEDANCE VARIATIONS, SHORT V-V INTERVALS, AND NON-SUSTAINED TACHYCARDIA EPISODES WITH ARTIFACT. THE LEAD IS STILL 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
    258695 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR