BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2952071 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00387
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    September 20, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    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. PERFORMANCE DATA RECEIVED FROM THE DEVICE WAS ANALYZED AND REVEALED LOW RIGHT VENTRICULAR DEFIBRILLATOR LEAD IMPEDANCE AND OVERSENSING, WITH 10 VENTRICULAR NST EPISODES BETWEEN 2012 (B)(4) AND 2012 (B)(4). A LEAD INTEGRITY ALERT WAS TRIGGERED ON 2012-10-03. CONCOMITANTS PRODUCTS: 4196 IMPLANTABLE PACING LEAD 2009 (B)(6), 5076 IMPLANTABLE PACING LEAD 2009 (B)(6). (B)(4).

    Description of Event or Problem · 1

    PERFORMANCE DATA WAS RETURNED TO THE MANUFACTURER, ANALYZED AND REVEALED A LEAD INTEGRITY ALERT DUE TO LOW RIGHT VENTRICULAR LEAD DEFIBRILLATOR IMPEDANCE. 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
    57055 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR (B)(4) IMPLANTABLE DEFIBRILLATOR