BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 3801309 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10955
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    February 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO THE ER DUE TO AN ALERT FOR NON-SUSTAINED LEAD NOISE EPISODES. THERE WAS A MISMATCH BETWEEN THE SENSE AMP AND DISCRIMINATION CHANNEL LEADING TO THE ALERT DUE TO A SLOW VT EPISODE. PROGRAMMING CHANGES WERE DISCUSSED. PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279179 FORTIFY ASSURA VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR