BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812491 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16193
    Event Type
    Injury
    Date Received
    October 31, 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 FOR: (B)(4) - PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND REVEALED THAT THERE WAS IMPEDANCE - RESISTANCE/IMPEDANCE INCREASE. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAXIMUM VENTRICULAR PACE BI IMPEDANCE = 551 TO 1881 OHMS. THE LEAD INTEGRITY ALERT TRIGGERED THERE WAS 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR AND OVERSENSING. THERE WERE 15 - VENTRICULAR NON SUSTAINED TACHYCARDIAS <=190 MS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SEVERAL JUMPS IN THE RIGHT VENTRICULAR IMPEDANCE (RV) AND OVERSENSING. THE LEAD TREND SHOWED HIGH RV PACING LEAD IMPEDANCE. IT WAS NOTED THAT THERE WAS A PATIENT ALERT AND THE LEAD INTEGRITY ALERT TRIGGERED. THE LEAD WAS 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 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB