BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2791726 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14555
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND THE DISTAL CONDUCTOR HAD FRACTURED. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE HELIX WAS DISTORTED/BENT, AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. INTERFERENCE/NOISE WAS OBSERVED AS VENTRICULAR SHORT INTERVAL COUNT WAS 783 COUNTS, IN 0.85 DAY, BETWEEN (B)(6) 2012 16:45:15 AND (B)(6) 2012 13:10:09. IT WAS ALSO NOTED THAT ONE LEAD INTEGRITY ALERT WAS TRIGGERED FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 07:34:10. HIGH RESISTANCE/IMPEDANCE WAS NOTED AS ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2012 15:00:10. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MAX VENTRICULAR PACE BIPOLAR IMPEDANCE FROM 646 TO 3610 OHMS PEAK BETWEEN (B)(46) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD FRACTURED AS HIGH IMPEDANCE, OVERSENSING, AND NOISE WERE OBSERVED. ALSO AN ALERT FOR LEAD INTEGRITY HAD BEEN TRIGGERED. 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
    1 SPRINT QUATTRO SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D234TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB