BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2790596 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14151
    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 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): PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE AND ANALYZED. THERE WAS ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. THE ALERT WAS FOR RIGHT VENTRICULAR BIPOLAR LEAD IMPEDANCE GREATER THAN 3000 OHMS. THERE WAS ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR VALUE ON (B)(6) 2012. THERE WERE TWO VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 205 MS ON (B)(6) 2012. THERE WERE FIVE LEAD FAILURE PREDICTOR HIGH RATE NONSUSTAINED EPISODES LESS THAN OR EQUAL TO 212 MS PER AVERAGE VENTRICULAR CYCLE BETWEEN (B)(6) 2012. THE VENTRICULAR SHORT INTERVAL COUNT WAS 145.4 COUNTS ON AVERAGE PER DAY IN 1.89 DAYS BETWEEN (B)(6) 2012. THE DEVICE WAS ALSO RETURNED AND ANALYZED. IT WAS NOTED THE DEFIBRILLATION COIL WAS FRACTURED AND DISTORTED. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON THE DEFIBRILLATION CONDUCTOR. THE OUTER INSULATION HAD A BREACHED DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THERE WAS TISSUE ON THE HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD ALERT TRIGGERED DUE TO HIGH PACING LEAD IMPEDANCE WITH OVERSENSING AND NOISE. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. 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 41 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB