BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2953546 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01200
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCTS: 4196 IMPLANTABLE PACING LEAD 2012 (B)(6); 4076 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT WITHIN ONE WEEK POST IMPLANT THAT THE PATIENT WAS FEELING TIRED AND THE PATIENT HAD A CONCERN THAT THE FATIGUE WOULD CONTINUE. FOLLOW UP WITH THE CLINIC FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INCREASED THRESHOLD AT THE ONE WEEK CHECK. THE PATIENT WAS REEVALUATED A WEEK LATER TO SEE IF THE INCREASED THRESHOLD HAD RESOLVED, AND EVERYTHING WAS CONSIDERED TO BE FINE AND THE PATIENT'S SHORTNESS OF BREATH HAD RESOLVED. THE RV LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57475 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR