BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 4354786 · Received December 22, 2014

    Report

    Report Number
    2938836-2014-18983
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    October 13, 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
    CO, US
    Reporter Occupation
    NURSE

    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 SHORT DURATION AMS EPISODES CAUSED BY P WAVES LANDING IN PVARP, FOLLOWED BY SENSOR DRIVEN AP EVENTS WERE OBSERVED. IT WAS RECOMMENDED TO EVALUATE FOR RETROGRADE P-WAVES, MAKE PROGRAM CHANGES TO THE DEVICE, AND MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841719 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR