BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3992065 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10075
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A LEAD IMPEDANCE OUT OF RANGE ALERT, AND THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. AN OUT OF TOLERANCE (OOT) SUB THRESHOLD LEAD IMPEDANCE ALERT OCCURRED 2014-(B)(6). MAXIMUM VENTRICLE PACE IMPEDANCE DROPS FROM 703 OHMS THE WEEK ENDING 2014-(B)(6), TO 304 OHMS THE WEEK ENDING 2014-(B)(6).

    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 FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. HOWEVER, THE EXPOSED RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING AND PULLING/STRETCHING/OVERSTRESS. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THERE WERE NO ANOMALIES OBSERVED REGARDING THE RETURNED LEAD. ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS. THE ANCHORING SLEEVE WAS NOT RETURNED AND THERE WERE NO ANOMALIES OBSERVED REGARDING THE INSULATION. AN INSULATION BREACH WAS NOT OBSERVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE WEEKS AFTER IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH PACING THRESHOLDS AND LOW IMPEDANCE. IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, THE LEAD WAS AFFIXED WITH SUTURE DIRECTLY ON THE LEAD BODY, AS SUTURE SLEEVE WAS INSIDE THE CEPHALIC VEIN. THE RV 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
    470190 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R