BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR, DF4 CONNECTOR

    MDR report key: 3210777 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03400
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 5, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PRESENTED TO THE ER AFTER RECEIVING MULTIPLE INAPPROPRIATE SHOCKS. UPON INTERROGATION, MULTIPLE EPISODES OF SVT WERE OBSERVED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309930 FORTIFY ASSURA DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR