BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3153718 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06190
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. ANALYSIS REVEALED RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE WAS OUT OF RANGE HIGH. PATIENT ALERTS FOR RV PACE LEAD IMPEDANCE GREATER THAN 3000 OHMS ON (B)(6) 2013. DAILY PACE LEAD TREND DATA SHOWS AN INCREASE FOR V PACE EQUAL TO 456 TO 16382 OHMS PEAK BETWEEN (B)(6) 2013. THERE WAS ALSO RV OVERSENSING WITH 28 VENTRICULAR NON-SUSTAINED TACHYCARDIA¿S LESS THAN EQUAL TO 210MS BETWEEN (B)(6) 2013. THERE WAS A VENTRICULAR FIBRILLATION EQUAL TO 130MS AVERAGE V-CYCLE ON (B)(6) 2013. AND NON-PHYSIOLOGICAL OVERSENSING WITH VENTRICULAR SHORT INTERVAL COUNT EQUAL TO 398 COUNTS, IN 0.85 DAY BETWEEN (B)(6) 2013. CONCOMITANT MEDICAL PRODUCTS: 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A HIGH NUMBER OF SHORT INTERVALS DETECTED. THE RV LEAD HAD SUSPECTED INSULATION DAMAGE. THE RV LEAD WAS CAPPED 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
    257501 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R