BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2953645 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01332
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    December 11, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD HAS BEEN STEADILY CLIMBING AND IS NOW HIGH. IT WAS ALSO NOTED THAT THE PACING THRESHOLD HAS INCREASED. THE LEAD WILL BE MONITORED AND 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
    55602 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR