BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 3914552 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13074
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 14, 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
    AZ, 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 PRESENTED IN CLINIC AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY FOR SVTS. THE PATIENT HAS A HISTORY OF ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND IS SCHEDULED FOR A PULMONARY VEIN ISOLATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390372 FORTIFY ASSURA VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR