BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE® DXAC/DSP

    MDR report key: 2951673 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00165
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 5, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THE OUTER INSULATION WAS BREACHED FROM THE FIRST RIB/CLAVICLE. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR DEFIBRILLATION COIL WAS PULLED/STRETCHED/OVERSTRESSED AND FRACTURED, THERE WAS BLOOD INGRESSION IN THE INNER INSULATION, AND THE LEAD WAS STRETCHED. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND VENTRICULAR SHORT INTERVAL COUNT V-SIC IS 1980 COUNTS, IN 13.41 DAYS, BETWEEN (B)(6) 2012. THREE PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED BETWEEN (B)(6) 2012. WEEKLY PACE LEAD TREND DATA SHOWS AN ABRUPT INCREASE FOR MAX RIGHT VENTRICULAR PACE OF 704 TO 12464 OHMS PEAK BETWEEN (B)(6) 2012; 15 VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES OF LESS THAN OR EQUAL TO 180 MS OCCURRED 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. (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 THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH PACING IMPEDANCE AND OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56241 SPRINT QUATTRO SECURE® DXAC/DSP DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

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