BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790491 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14144
    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) WE RECEIVED PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING WAS NOTED WITH FIVE VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 180 MS BETWEEN (B)(4) 2012 AND (B)(4) 2012. THERE WERE FIVE LEAD FAILURE PREDICTOR HIGH RATES, NON-SUSTAINED LESS THAN OR EQUAL TO 212 MS AVERAGE V-CYCLE BETWEEN (B)(4) 2012 AND (B)(4) 2012. INTERFERENCE/NOISE WAS NOTED WITH A VENTRICULAR SHORT INTERVAL COUNT EQUAL TO SIX COUNTS AVERAGE PER DAY, IN 6.79 DAYS, BETWEEN (B)(4) 2012 AND (B)(4) 2012. LEAD INTEGRITY ALERT TRIGGERED WITH ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4) 2012. HIGH RESISTANCE/IMPEDANCE WAS NOTED WITH TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012 AND (B)(4) 2012. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MAXIMUM VENTRICULAR PACE BIPOLAR IMPEDANCE EQUAL TO 551 TO 4047 OHMS PEAK BETWEEN (B)(4) 2012 AND (B)(4) 2012. THE LEAD WAS RETURNED IN SEGMENTS AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED. THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER TUBING OVERLAY WAS MELTED AND HAD BLOOD/BODY FLUID ON IT. THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND MECHANISM (SLEEVE HEAD). VISUAL ANALYSIS NOTED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCE PEAKS AND AN INCREASE OF THRESHOLDS. A REVIEW OF THE PRODUCT PERFORMANCE DATA SHOWED THAT THE LEAD INTEGRITY ALERT TRIGGERED AND THAT THE LEAD HAD A HIGH NUMBER OF SENSING INTEGRITY COUNTS AND WAS SENSING NOISE. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB