BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE® DXAC/DSP

    MDR report key: 2951622 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00145
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 2, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS APPARENT EXPLANT DAMAGE. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND THERE WAS INTERFERENCE/NOISE. VENTRICULAR SHORT INTERVAL COUNT V-SIC OF 15 COUNTS, IN 0.31 DAY, OCCURRED ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 01:31:47 AND 09:01:52. HIGH RESISTANCE/IMPEDANCE WAS ALSO OBSERVED. FIVE PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED BETWEEN (B)(6) 2012. WEEKLY PACE LEAD TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAX RV PACE= 475 TO 4047 OHMS PEAK BETWEEN (B)(6) 2011 AND (B)(6) 2012. THE LEAD INTEGRITY ALERT TRIGGERED. ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012.

    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. CONCOMITANT PRODUCTS: 5076, IMPLANTABLE PACING LEAD, (B)(6) 2010; 4194, IMPLANTABLE PACING LEAD, (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH AND VARYING PACING IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD AND AN ALERT WAS TRIGGERED. FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55698 SPRINT QUATTRO SECURE® DXAC/DSP DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR