BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2953242 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00987
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    July 1, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PRODUCT : 4076 IMPLANTABLE PACING LEAD 2007 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD PACE/SENSE IMPEDANCE HAD INCREASED OVER A FOUR MONTH PERIOD AND WAS NOW HIGH. THE THRESHOLD HAD ALSO INCREASED. IT WAS NOTED THAT THE PATIENT HAD OPEN HEART SURGERY AND SUBSEQUENTLY, THE IMPEDANCE BASELINE BEGAN TO CHANGE. THE LEAD REMAINS 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
    55991 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR (B)(4) IMPLANTABLE DEFIBRILLATOR