BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2791254 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14513
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER TUBING OVERLAY MELTED, THE OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING, THE INNER INSULATION WAS TORN, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS TISSUE ON THE HELIX. IT WAS VISUALLY NOTED THAT THE BLOOD IN THE DISTAL CONDUCTOR MOST LIKELY ENTERED THROUGH THE IS-1 PIN BECAUSE NO OUTER INSULATION BREACHES WERE OBSERVED. (B)(4) WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WERE FOUR VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES OF LESS OR EQUAL TO 210 MS BETWEEN (B)(6) 2012. ONE RECORDED VENTRICULAR FIBRILLATION OF170 MS AVERAGE V-CYCLE ON (B)(6) 2012. THERE WERE FIVE LEAD FAILURE PREDICTOR (6) 2012. THERE WAS ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT TRIGGERED. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD SHOWED OVERSENSING AND NOISE. THE LEAD WAS PARTIALLY REMOVED, THE REMAINDER 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
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R D364TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB