BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2953691 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01262
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    March 23, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 5076, IMPLANTABLE PACING LEAD, (B)(6) 2009; 4194, IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INTERMITTENT T WAVE OVERSENSING THAT FORCED P WAVES INTO A POST-VENTRICULAR ATRIAL REFRACTORY PERIOD SO THEY WERE NOT ABLE TO BE TRACKED. ADDITIONALLY, AN ELECTROCARDIOGRAM SHOWED PAUSES IN THE PATIENT'S VENTRICULAR RATE. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55731 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR