BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 3872916 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11843
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN HOSPITAL FOR ROUTINE FOLLOW UP. DEVICE INTERROGATION REVEALED A VF EPISODE THAT WAS NOT CONVERTED WITH A HIGH VOLTAGE SHOCK. THE PATIENT RETURNED TO SINUS RHYTHM SPONTANEOUSLY. A DFT TEST WAS SUCCESSFULLY PERFORMED AND THE DEVICE REMAINS IMPLANTED. PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349492 FORTIFY ASSURA VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1259-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1