BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR, DF4 CONNECTOR

    MDR report key: 3801326 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10966
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 5, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE ATP AND HV THERAPY FOR AN SVT WITH RVR. UPON INTERROGATION, SVT EPISODES WERE BEING DETECTED AS VT. THE ICD WAS REPROGRAMMED AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278820 FORTIFY ASSURA VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention