BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3051098 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04731
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: TDK061047V: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS R ECEIVED AND ANALYZED. ANALYSIS REVEALED THERE WAS LOW RESISTANCE/IMPEDANCE AND TWO PATIENT ALERTS WERE NOTED FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. WEEKLY PACE IMPEDANCE TREND DATA SHOWED A DECREASE FOR THE MAXIMUM AND MINIMUM VENTRICULAR PACE BIPOLAR IMPEDANCE FROM 456 OHMS TO 247 OHMS AND MINIMUM IMPEDANCE NOTED BETWEEN (B)(6) 2012 AND (B)(6) 2013. CONCOMITANT PRODUCT: 5076 NON-DEFIB LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO CAPTURE AND UNDERSENSING ON THE VENTRICULAR LEAD. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAD TO CUT AWAY SILICON IN ORDER TO INSERT THE WRENCH INTO THE SETSCREW TO REPOSITION LEAD.THE DEVICE WAS EXPLANTED AND A NEW DEVICE 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
    148414 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R D314DRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR