BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA ST VR

    MDR report key: 4760318 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04689
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    March 11, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF LONG CHARGE TIME WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE AND WAS DUE TO CAPACITOR MAINTENANCES. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. THE LONG CHARGE TIME COULD NOT BE REPRODUCED. THE CAUSE OF THE LONG CHARGE TIME COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT FOR LONG CHARGE TIME WAS NOTED DURING THERAPY FOR AN EPISODE OF VENTRICULAR FIBRILLATION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303610 FORTIFY ASSURA ST VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1359-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention