BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY VR, U1.6 DF1 US

    MDR report key: 8621270 · Received May 17, 2019

    Report

    Report Number
    2017865-2019-08331
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 7, 2019
    Report Date
    May 17, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734504355
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE EVENT WAS OBSERVED DURING ANALYSIS. AUTOMATIC TEST EQUIPMENT (ATE) WAS USED AND FOUND FAILURES ON THE RIGHT VENTRICULAR CHANNEL. BENCH TESTING ALSO FOUND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED HIGHER THAN NORMAL HIGH VOLTAGE LEAD IMPEDANCE (HVLI). THE CAUSE OF HIGH HVLI AND ATE FAILURES WERE ISOLATED TO THE U1 IC ANOMALY.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413310 FORTIFY VR, U1.6 DF1 US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD1231-40 3632598 05414734504355

    Patients

    Seq Age Sex Outcome Treatment
    1