BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2811990 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16647
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4). THE ACTUAL LEAD INVOLVED IN THE EVENT WAS NOT RECEIVED; HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. HIGH RESISTANCE/IMPEDANCE: 1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 21:00:09. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MIN AND MAX VENTRICULAR PACE BI IMPEDANCE = 457 TO 1558 OHMS PEAK BETWEEN (B)(6) 2011 AND (B)(6) 2012. LEAD INTEGRITY ALERT TRIGGERED: 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2011 22:58:23. SENSING/OVERSENSING: 14 - VENTRICULAR NST <=190 MS BETWEEN (B)(6) 2012 17:08:35 AND (B)(6) 2012 23:39:05.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT ALERT DUE TO NOISE, OVERSENSING, HIGH AND FLUCTUATING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. AT THIS TIME THE PATIENT WILL BE OBSERVED FOR THE NEXT FOUR WEEKS AND NO CHANGES HAVE BEEN MADE. THE RV 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
    1 SPRINT QUATTRO SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB