BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, U1.6 DF1 US

    MDR report key: 9471032 · Received December 15, 2019

    Report

    Report Number
    2017865-2019-17981
    Event Type
    Malfunction
    Date Received
    December 15, 2019
    Date of Event
    November 25, 2019
    Report Date
    December 15, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734504379
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED VIA REMOTE TRANSMISSION. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DELIVERED A SHORTED OUTPUT STAGE DETECTION ALERT, IN WHICH THERE WAS POSSIBLE HIGH VOLTAGE CIRCUIT DAMAGE. NO INTERVENTION ON THE DEVICE WAS PERFORMED AND THE PATIENT WAS PROVIDED A LIFE VEST DUE TO OTHER HEALTH CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265435 FORTIFY DR, U1.6 DF1 US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2231-40 3660532 05414734504379

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR