BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2964987 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01983
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 29, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND THE PROXIMAL LOW VOLTAGE CONDUCTOR WAS FRACTURED FROM BEING FLEXED. ALSO, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED AND IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE WAS OUT OF RANGE HIGH WITH FOUR PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE (B)(6) 2013. DAILY PACE LEAD TREND DATA SHOWS AN INCREASE FOR VENTRICULAR PACE BI IMPEDANCE EQUAL TO 342 TO 4047 OHMS PEAK BETWEEN (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS AND THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE AND HIGH THRESHOLD. IN THE COURSE OF EXPLANTING THE RV LEAD, THE ATRIAL LEAD BECAME DISLODGED. ACCESS FOR THE NEW RV LEAD WAS ACHIEVED AND THE RV LEAD WAS REPLACED, BUT THE PHYSICIAN WAS NOT ABLE TO GAIN ACCESS TO ADD A NEW ATRIAL LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68255 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| L| R 4076-45 IMPLANTABLE PACING LEAD