BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 5859338 · Received August 9, 2016

    Report

    Report Number
    2649622-2016-08686
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    May 11, 2016
    Report Date
    May 11, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND VARIABLE. IT WAS NOTED BEGINNING (B)(4) 2015, THE RV PACING IMPEDANCE VARIED BETWEEN 380-1691 OHMS. THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT CANNOT BE CONFIRMED THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. IT IS INCLUDED IN THE FIELD ACTION IN THE ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNSTABLE PACING IMPEDANCE, FROM WITHIN-RANGE VALUES TO HIGH VALUES. THE RV LEAD WAS ABANDONED 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
    510929 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R